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DR. THOMAS J. KENNEDY, JR. 'S 
SPEECHES AND ARTICLES 



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SPEECHES AND ARTICLES BY DR. THOMAS J. KENNEDY, JR. 



DATE 



PLACE 



TITLE 



See 
TAB 



4/24/69 Galveston, 
Texas 



2/6/70 Chicago, 111. 

PUBLISHED 



2/25/71 "Linden Hill' 

5/14/71 NSF 

5/20/71 NTH 

12/9/71 N.Y. 



2/11/72 
PUBLISHED 



2/29/72 NIH 



2/22/73 NIH 



3/29/73 



Wash. , 
D.C. 



"The outlook for careers in biomedical 1 
research. " Presented at the 1969 SAMA- 
UTB National Student Research Forum. 

"National expenditures for biomedical 2 

research. " Co-authored by Drs. 
Robert W. Berliner & Dr. Thomas J. 
Kennedy, Jr. Published in the 
Journal of Medical Education , Vol. 

45, Sept. i~wnr. 

Chart presentation before the AD HOC 3 

Advisory Group on Simulation Models. 

"Academic science support programs 4 

of the NIH. " Presented before the 
Advisory Committee for Planning, 
NSF. 

Dedication of the Primate Building. 5 

"Comments on the paper of Dr. Ivan L. 6 
Bennett entitled 'support of research 
and graduate education in the United 
States. ' " Delivered in the seminars 
on science and public policy at 
Rockefeller University. 

"Factors contributing to current 7 

distress in the academic community. " 
Co-authored by Drs. Kennedy, Sherman, 
& Lamont-Havers. Article published in 
Science , Vol. 175, Feb. 11, 1972. 

"Basis for determining resource 8 

allocation for biomedical research. " 
Delivered at NIH orientation for HEW 
management interns. 

Chart presentation before the Director's 9 
Advisory Committee (new council 
members). 



"NIH research program -project and 
center grants. ' Presented before the 
Amer. Assoc, of Med. Colleges (AAMC). 



10 






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SPEECHES AND ARTICLES BY DR. THOMAS J. KENNEDY, JR. (Cont. ) 



DATE 
6/4/73 



PLACE 

NIH 



6/15/73 Manhattan, 

Kansas 



6/26/73 NIH 

12/3-4/73 NIH 



1/29/74 



TITLE 

Untitled speech. Given as a keynote 
address for the program planning 
session sponsored by the STEP 
Committee, NIH. Topic: Staff 
training for extramural programs. 

"Prospects for federal support of 
biomedical research. " Prepared 
for delivery before the Society of 
Developmental Biology, Inc. 

Chart presentation before the DAC. 

"An experimental alternative to ^ 
program project and center grants. 
Presented at the Director's 
Advisory Committee (DAC) meeting. 

Slide presentation. Delivered at the 
Inter-council meeting. 



See 
TAB 

11 



12 



13 
14 



15 



3/31/75 



-Given-as-an-official-of-the-AAMC- 



"Status of funding of NIH /NIMH 
sponsored research. " Presented 
before the spring meeting of the 
Council of Academic Societies, 
Assoc, of American Med. Colleges 
(AAMC). 



16 



DO 



THE OUTLOOK FOR CAREERS IN BIOMEDICAL RESEARCH* 

By 

Thomas J. Kennedy, Jr., M.D.** 



Dr. Blocker, Mr. Ferguson, Ladies and Gentlemen: 
I am honored by your invitation to address this meeting and only 
hope that the subject matter I have chosen will strike a responsive 
chord. In considering various possible themes, I reflected that this 
meeting would be peopled by young men and women either beginning a 
career in medical research or nibbling at this activity as a career 
alternative. Each of you has arrived at your present outlook through 
some magical combination of internal drives --for more knowledge, better 
understanding, less uncertainty- -and external inspiration. The chal- 
lenge of the unknown has in some measure formed your attitudes and aspi- 
rations. And you have undoubtedly been influenced by your educational 
environment, whose standards of excellence and scholarship have also 
molded your thinking and your ambitions. I have no credentials that 
permit me to speak with authority in these areas. I would propose, 
instead, to explore the purely administrative dimensions of the human 
activity called research, mentioning some of their implications for 
the investigator. 



*Presented at the 1969 S.VIA-UTB National Student Research Forum, 
Galveston, Texas, April 24, 1969. 

^"•'Associate Director for Program Planning and Evaluation, Office of 
• -the Director, National Institutes of Health. ■ 



2 
My first thesis is that research in general , and biomedical 
research in particular, are to a very significant extent an activity 
of the public and not the private sector. Slide 1 depicts schematically 
the growth of the Nation's research and development since 1950. At that 
time the estimate of expenditures for all RfjD in the United States was 
$2.9 billion, of which $161 million, or about 5 percent, was allocated 
to biological and medical research activities. By 1968 the comparable 
estimate for all R$D was $25 billion, of which about $2.5 billion, or 
10 percent, went for biomedical R$D. 

Slide 2 represents our country's growing investment in R§D over 

the last two decades, and indicates the shift in emphasis to 

during the last decade. 
the problems of biology and medicine/ We see that the Nation's invest- 
ment in research is substantial, both in absolute terms and in relation 
to our gross national product- -currently about $900 billion per annum. 

Slide 3 outlines the rate of growth in the contribution of several 
sectors to the total national investment in biomedical research. Several 
points emerge clearly. The Federal Government has assumed the pre- 
eminent role as patron of biomedical research, reaching parity with the 
nonfederal sector in the 1950 's and eclipsing it in the 1960's. 
Industrial investments have also grown rapidly. 

Slide 4 , in which comparable data are presented in tabular form, 
shows that Federal sources have steadily increased, both absolutely-- 



3 



from $27 million in 194 7 to $1.6 billion in 196S--and relatively- - 
from 31 percent of our total national investment in 1947 to 64 percent 
in 1968. 

Slide S shows in somewhat greater detail the contribution of the 
several sources of funds at various points in the time series. It 
emphasizes the relatively slow growth of contributions from the 
nonindustrial private sector. 

Slide 6 is a graphic representation of where the researcli money 
comes from and where it is consumed. It is important to note that the 
funds contributed by industry are expended almost exclusively in 
industrial laboratories. Funds contributed to the national effort by 
the Federal Government are expended in Federal laboratories such as 
those of the National Institutes of Health at Bethesda; in academic 
institutions; in research institutes, hospitals, and State and local 
health departments; and to a limited extent, in the laboratories of 
industry. 

Slide 7 outlines the contributions of the Federal agencies most 
heavily engaged in the support of biomedical science. The Department 
of Health, Education, and Welfare is by all odds the most significant 
of the Federal agencies, having steadily consolidated its position of 
preeminence. You will note that one component of the Department, the 
National Institutes of Health, is responsible for the lion's share of 
the DHEW activities in this field. As compared with DHEV', Federal 



: 4 

agencies such as DoD, AFC and NASA, which account for 85 percent of all 
Federal RQD expenditures, contribute only modestly to biomedical 
research . 

This series of slides, then, presents data in support of my first 
thesis--to wit, that biomedical research is a function of the public, 
not the private sector. A corollary is that one who aspires to a career 
in science, and especially in biomedical science, will be heavily and 
inescapably dependent upon public policy decisions. 

My second thesis is that it behooves the investigator to know 
something about the nature and the functions of the public institu- 
tions that will exert such a profound influence over his career. For 
purposes of this discussion a general description of the National 
Institutes of Health will serve as an introduction to agencies in the 
Executive Branch of Government, and on this I can speak from considerable 
experience. Since the Executive proposes but the Congress disposes, 
a rounded survey also calls for a look at the legislative processes. 

The modern history of the National Institutes of Health begins 
with the end of World V, T ar II, when the agency was assigned responsi- 
bility for biomedical research contracts between the wartime Office 
of Scientific Research and Development and 'public and private research 
organizations. Slide 8 shows the pattern of NIH growth as well as 
the types of support -it provides. The bulk of its funds have supported 



research projects, either conducted directly on the Bethesda campus 
or through research grants to investigators throughout the country. 
Training grants to develop human resources for research have been 
awarded since the late 1940' s, and grants for the construction of 
physical facilities, since 1957. 

derived from appropriation data also 
S lide 9 / indicates the categories of scientific problems which 

have commanded attention through these diverse mechanisms. The first 
tier represents the National Institutes of Health that have come 
into being since 1957 through legislative enactments- -the National Cancer 
Institute, National Heart Institute, etc. DBS stands for the Division 
of Biologies Standards, which conducts a research and regulatory function 
dating from 1902. The Institutes' names and the magnitude of the 
Congressional appi-opriations for their activities reflect the nature 
and extent of public concern for major classes of disease. It is 
the task of the Federal bureaucrat to devise the machinery for trans- 
lating such mandates into scientifically sound programs. 

Slide 10 illustrates how this works out in practice, using a 

single Institute as an example. Of the billion- odd dollars appropriated 

to the Nil! in fiscal year 1967, $164 million was earmarked by the Congress 

for the National Heart Institute. $127 million of this amount was 

spent for research (vis a vis training, general support and other 

nonresearch activities). The research actually funded can be broadly 

classified as related to atherosclerosis, hypertension, other ' 

etc. 

vascular disease?./ Further subclassifi cation of atherosclerosis and 
into etiology, diagnosis and therapy 
hypertension Are possible, as shov.n. 



vascular diseases. 

Slide 11 gives a comparable breakdown of the expenditures of 

the National Cancer Institute. Obviously each segment of each pie 

chart could be exploded into finer and finer subdivisions. Thus we 

by Congress 
see how funds appropriated/ for broad missions like the control of cancer 

can be readily recognizabb 

®3s/programmed into research efforts addressed to objectives/ 

by scientists as research opportunities. 

As a slight digression, you might be interested in the process 
whereby a research grant is awarded. Slide 12 illustrates that the 
process begins in the imagination of the investigator. He submits 
an application, through his institution, to a division of NIH--the 
Division of Research Grants--whose major function is to provide an 
objective scientific evaluation of the proposal. The applications 
that survive the process- -about 55 percent- -are then referred to the 
appropriate National Institutes for examination of their relevance 
to the Institutes' missions. 

Clearly the universe of medical research is far broader than 
the ten categories included in the names of the ten National Institutes. 
Clearly also, it is not within the realm of the practical or feasible 
to have a National Institute for each disease to which man is prone 
-or for each organ of. -the body. Over the years, the domain of each 
Institute has been broadened by arbitrary assignment of responsibility 
for programs not clearly inherent in its title. 



It is important to note that responsibility for each decision on 
scientific merit and program relevance is in the hands of advisory 
groups- -study sections and National Advisory Councils- -composed of 
non -Government people. The process is one- which those of you who 
remain in research will become quite familiar with, both as applicants 
and later as members of advisory bodies. 

For some time it has been evident that the viability of a 
national research effort depended on support for more than the 
traditional research projects. Slide 1 3 indicates the types of . 
support mechanisms that have developed in recent times, together 
with a rough measure of the funding for each. 

Special resource awards, for instance- -mainly to centers devoted 
to primate biology, clinical research, computation and data processing- - 
have been established. Large umbrella awards called program projects, 
which fund under one instrument a series of coherent activities, 
have been created. In instances where the Government is able to specify 
exactly what it expects, as in the case of technical development efforts, 
research contracts permitting virtually no freedom of movement to the 
investigator have come into use. 

To sustain, renew and expand the research effort, training grants 
to institutions and fellowship awards to individuals on a nationally 
competitive basis have emerged as important components of the Institutes' 
programs. Finally, the need for ndnhuman resources- -rbricks and mortar-- 



8 

is met through programs for the construction of educational and research 
facilities. Again, many of you will soon be personally involved in 
NIH-supported fellowship and training grant programs. 

Let me move now to a rather crucial question. How does NIH 
get the money to disperse through this array of mechanisms? Slide 14 
is a map of the budgeting process whereby NIK begins in the spring of each 
year and ends some 18 to 21 months later with money in hand. The route 
is tortuous, and for today's purposes we need only give it the most 
genera], treatment . 

The first part of the cycle, taking approximately one year, 
..represents a battle to get the right words into the President's annual 
budget message to the Congress. The proceedings are, I think,basically 
adversary. Each Institute devotes its energies to the realization of 
a budget that most, closely approximates its estimate of the needs and 
opportunities in its domain of responsibility and authority. 

Arrayed against the importunings of the Institutes stand the 
President's organizations for fisal matters- -the Council of Economic 
Advisors, the Bureau of the Budget, the Treasury, the Internal Revenue 
Service. Their staffs must assess the state of the national economy, 
the economic and political feasibility of taxation schemes, the probable 
revenue available to -the Government. They must lay before the 
President the consequences of various total levels of expenditure and 
various degrees of balance or imbalance of the budget. Finally, they 



must reconcile- -within the decided total level of national expenditures -- 

the competing claims of all the Federal agencies. 

The process then entails upward justification of the initial 
proposals against ceilings set by higher authority. The NIH Director 
must reconcile the competing claims of the Institutes; the Assistant 
Secretary for Health and Scientific Affairs, the competing claims of 
research, environmental health, and health services; and the Secretary, 
the competing claims of the health, education, and welfare sectors. 
The outline before you idealizes the process. In point of fact, it is 
replete with all sorts of epicycles and feed-back loops, with less 
and less time available for decisions as the deadline for the printing 
of the President's Budget nears. 

In January of each year, the dialogue within the Executive Branch 
ceases with the submission to the Congress of the President's Budget for 



to on the com in 



£> 



the fiscal year /begin begin /July 1. During the spring, the cognate 
Congressional appropriations subcommittees hold hearings in which 
the responsible officials of the Executive agencies are called upon 
to defend and justify the President's requests. Recommendations of 
these subcommittees, as modified and approved by the full Appropriations 
Committee, are then debated, amended, and eventually submitted to vote 
for the approval of the House and the Senate. When the two appropria- 
tions bills differ substantially, differences must be reconciled by a 
Conference Committee made up of members from each body, and then the 
Conference Bill is resubmitted to both houses. 



10 

During the hearing process, interested citizens have been permitted 
to submit their views for the record, either in person or in writing. 
In this way the Congress gets some sense of the breadth, depth and 
weight of public interest. 

Slide 15 from the Congressional Record reflects a little-recognized 

fact of life. If one assumes, particularly at a time like the present, 

that the funds for National Defense are relative irreducible, SO percent 

of the $200 billion Federal budget is fixed and mandatory. All the 

domestic programs, including those in health research and health 

professions education, must come out of the remaining 20 percent. 
/V/- : - /est ssrcocc/ 

Slide 16 depicts the controllable and noncontrollable items in 
the budget of DUEW, and reveals the disturbing fact that only $7 billion, 
or 12 percent of a total budget of almost $60 billion can be viewed 
as controllable. 

The significance of these facts lies in the effects of an unforseen 
contingency. Two broad types of contingency may arise: overestimation 
of revenues, and underestimation of mandator)' commitments. The task 
of predicting what the national tax and other revenue receipts will be, 
say in November or December of 1968 for the fiscal year ending on June 
30, 1970, is never less than formidable. Nor is the task of estimating 
mandatory costs a simple one. Many Federal obligations are open-ended- - 
for example, those committed to the reimbursement of individuals who 
have made predetermined contributions. 



11 

The point I wish to press here is that errors in forecasting must 
be referred to the controllable and not to the total budget. Moreover, 
a $10 billion deficit over anticipated assets- -well within recent 
precedents, by the way- -may represent only a 5 percent error when referred 
to the $200 billion budget, but will actually entail a 25 percent 
reduction in controllable expenditures, to maintain the degree of 
balance deemed advisable by the President. 

My third thesis is that in a fiscal crunch, research is among the 
most vulnerable items in the Federal Budget. To many, research is the 
open sesame to the solution of a whole gamut of human problems . 
It is seen as the one and only hope to reduce the human and social 
costs. And this is particularly true in the field of health. For 
example, neoplastic disease takes a tremendous toll in human lives as 
as result of our inability to cope with the neoplastic process. In 
addition, the social costs--in losses to the labor force, in medical 
and hospital expenses, in welfare payments to dependents, etc. --are 
enourmous. Most of us share the belief that the situation is not likely 
to improve unless scientific efforts are successful in creating new 
knowledge and fresh insights. 



u o 



Unfortunately, this view has not permeated broadly and deeply 
into the fabric of our national thinking. As a consequence, Federal 
officials must provide an annual accounting for expenditures, and tend 
to operate in a context in which there are implicitly required, if not 



12 

explicitly demanded, expectations for annually reportable, major 
scientific breakthroughs. In part, this circumstance reflects a 
misunderstanding of the processes of scientific research; in part, 
a measure of the fierce competition for resources in contemporary 
society. 

Even the scientist may find it useful now and then to pause and 
contemplate the secular course of activities in which he partakes. 
Slide 17^ illustrating such a digression, is adapted from a study 
supported by the National Science Foundation and conducted by the 
Illinois Institute of Technology Research Institute. The study is 
entitled "Technology in Retrospect and Critical Events in Science"- - 
acronym, TRACES. It has traced here the critical events in science 
and technology which culminated in the introduction of the electron 
microscope. If much of the detail in this and the next slide is 
illegible, the points I wish to emphasize do not depend on this detail. 

Note that the important technological achievement represented 
here has roots traceable to about 1860. It depended on the convergence 
of a number of major lines of research and development: on the wave 
nature of light; the wave nature of electrons; electron sources, 
electron optics; and cathode-ray tube development. We see that 
"technical development and application" (symbolized by the green squares) 
is a very late phase in the process, and that "mission-oriented research- - 
signifying effort focussed on a practical goal in contrast to new knowledge 
for its own sake- -(symbolized in the blue triangles) is usually preceded 
by a long history of basic investigation. 



13 

Technological improvement, too, is likely to depend on fruition 

of a long chain f events in pure and mission-oriented research. For 

systems for electron microscopy 
example, the development of cryogenic lens/ became possible only with 

extensive advances in lov;- temperature physics. 

Slide IS depicts the history of events in steroid chemistry and 
hormone research and in the physiology of reproduction which culminated, 
at the beginning of this decade, in the oral contraceptive. Once 
again we see free-ranging non-mission research, followed by mission- 
oriented research, and finally by technical development and application. 

In this case, recycling can be observed. For example, in the earjy 
1930' s, hormone research by a number of distinguished scientists had 
reached the stage at which applicability was obvious, and the manufacture 
of hormones from animal sources for therapeutic use began. The 
availability of synthetic sex hormones in the early 1960 's, made possible 
by four decades of progress in steroid chemistry, stimulated and facili- 
tated a great deal of mission-oriented research. Finally, these lines 
of inquiry converged in tie 1950 's on the problem of contraception 
and culminated in the introduction of the "pill," a major milestone 
in the history of contraceptive technology. 

The last two charts suggest some of the difficulties in defending 
science budgets. It is fairly easy, looking through the retrospectpscope 
in 1909, to select that small portion of information published in 1930 



14 

which proved critical for the subsequent discoveries. But one may 
wonder what practical value could honestly have been foreseen for 
these findings in 1930. One may also speculate on whether in, say, 1980, 
with the advent of sane presently miforseeable achievement, we will 
attach signal importance to information which does not now seem critical 
for subsequent major developments. 

The scientist recognizes from his sense of history that some emerging 
bit of new knowledge, even though unidentifiable now, will in all 
likelihood form an essential link in the chain of events leading to 
important achievements. But the justification of public expenditures 
for research will be difficult until a far larger segment of the 
public understands this process of cumulative growth of scientific 
information and appreciates the difficulties of assessing isolated 
contemporary increments in knowledge. [Lights please] 

The annual agonizing reappraisal of research budgets reflects 
not only the difficulties encountered in perceiving causal relation 
between recent investments and major returns, but also the fact that 
many competing claims for research dollars to solve a vast array of 
problems are heard throughout the land. No. one has outlined the 
alternatives facing the Nation more eloquently than Mr. William Carey, 
erstwhile Assistant Director of the Bureau of the Budget. He asks: 



What are we going to do with (R$D) ? • Inspect the outer 
universe or the inner city? Discover new atomic particles 
or new routes to human understanding? Build better 



15 

accelerators or better neighborhoods? Probe the deep 
oceans or the causes of violence? Spend much on learning 
to prolong life and almost nothing on learning to use life? 
Shall we do all these tilings, or other tilings, or none of them? 

In the last few years, the most pressing preoccupation of the 
bureaucracy is how to order its priorities for investment among the 
competing claimants. The search for methodology, for a logical value 
system for ordering these priorities, and for optimizing the investment 
of public funds preempts the time and energies of some of our most 
dedicated public servants. It turns out that there is probably no 
calculus devisable to resolve these issues in black-and-white scientific 
terms. The problems are basically political, and solutions must be 
sought through the political processes which have evolved for our 
governance as a society. 

We may now be at the point at which my meandering explorations of 
the administrative context for medical research become relevant to your 
aspirations for careers in investigation. For by new it must be plain 
that the funding of such a career will be intertwined with the public 
policy decisions of the Federal Government. 

If career opportunities are to be provided in numbers commensurate 
with the challenges before us, the Executive and Legislative arms of 
the Government must consciously and deliberately make certain choices 
and long-term commitments. People with a large stake in these decisions 
can hardly' evade responsibility for them or avoid direct and personal 



16 

involvement. The critical role of science in human affairs demands 
that the scientist take an active part in creating the climate of 
public opinion Which will facilitate --yes, even force- -the public 
policy decisions for continued investments in research. 

In making this assertion, I am aware of the paradox that a 
career reputed to attract those more interested in "things" than in 
"people" is vitally dependent upon the ability of the research worker 
to persuade the average citizen of the importance of this pursuit. 

The scientific performance requirements for careers in biomedical 

research are in general known to most of you. As yet, little thought 

has been given to the additional nonscientific requirements imposed on 

the scientist in the last third of the 20th Century as a consequence 

of the Federal Government's emergence as the principal patron of science. 

I am no authority on these matters, but would like to offer a few random 

thoughts on the relationship between scientist and citizen. 

to the public 
The scientist's message/must clearly articulate all the values 

of research. The value most immediately apparent is, of course, the 

promise that research holds for the practicing physician. Research 

is the. key to progress. Further, the research process is extremely 

valuable in and of itself. For research is the method for graduate 

education in the sciences, and mastery of its techniques and viewpoint 

prepares the practitioner for the problem-solving exercises that 

characterize his occupation. Every physician can profit from an 

exposure to research in depth- -from the experience of formulating a 



17 

problem, working out an experimental design, accumulating data, 
evaluating results, recycling through the process to refine the 
formulation or the design, drawing conclusions, defending them 
through a review process, and publishing. Finally, research is the 
refinery for new teachers in our academic institutions, the founts inhead 
of replacement and renewal for retiring faculty, and the nuclei about 
which new schools are formed. ' 

As to the audience for the message of the scientist, the ultimate 
decision makers are the President of the United States and the members 
of the Congress. A number of scientists have functioned quite 
effectively in informing, educating and persuading key public officials 
at the highest level of government. They have accomplished this 
through person-to-person contacts, through representation of local 
constituencies and national organizations, through representation 
before Congressional committees , and so forth. Most legislators 
welcome expert advice, particularly when it comes from within their 
own communities. Its persuasiveness is directly proportional to the cogency 
of the argument, the stature of the advocate, and the public good at 
stake. 

The highest level of government is not the only arena in which 
the scientist can be publicly effective. Both the Executive and the 
Legislative Branches -are profoundly concerned with another issue- -the 
grass roots support accorded their decisions. This approach to broad 
citizen understanding and empathy has perhaps been less traveled than 



18 

the routes to Washington, D.C. Yet it is precisely at the local level 
that constituencies could be built, that systematic efforts to inform 
and educate could be undertaken, and that attempts to associate citizens 
with the grand undertakings and aspirations of research could yield 
large returns. 

To this end the investigator can address high school students, 
citizens' associations, PTA's, Kiwanis clubs, the League of Women 
Voters, etc. Research laboratories could hold "open house," to exhibit 
their work to the community and to make the ultimate supporter of 
the enterprise- -the taxpayer- -feel a part of it. Finally, patients could 
be encouraged to." learn about research activities and, in the case of 
those admitted to clinical research centers, be made aware that public 
funds were conducive to whatever benefit may have accrued. The steady, 
systematic cultivation of public understanding cannot fail to yield 
dividends in the form of stable and growing public support. 

Positive and constructive advocacy of research should recognize 
that as a human activity, it must compete in a market with other 
-attractive pursuits. Two threats are clearly discernible: research 
seems to be losing its appeal; and other activities, principally health 
services, are commanding an increasing measure of public attention. 

Why does research appear to be in eclipse? One reason is that 
it has become a large enough activity to be a prominent target, to 



19 

have committed errors, and to have acquired some enemies. In short, 
it has incurred a substantial degree of hostility. 

The social critic finds it a suitable target for the sly dig. 
Jacques Barzun, Provost of Columbia, follows his distinguished book 
on "The House of the Intellect" by one entitled "Science: The Glorious 
Entertainment." Daniel Greenberg opens an impressive enquiry into 
the relationship between science and the United States Government with 
a hierarchical description of the so-called Scientific Establishment. 
Just last month, Spencer Klaw published a book with the clever title 
"The' New Brahmins: Scientific Life in America." Such descriptions 
both reflect and foster the growing disenchantment with science and 
scientists. 

Research is also taking its lumps from students, some of whom 
see it as separating them from their teachers and contributing to 
the irrelevance of their education. Certainly, students have a legitimate 
complaint if they are inadequately taught and their curriculum is 
irrelevant. In my view students deserve nothing less than a well -taught, 
relevant curriculum- -a product unattainable outside an environment 
enriched by bold scientific inquiry. 

Perhaps even more strident in their derrogation of research- 
are the action-oriented individuals both within and outside the health 
professions. Faced with an overwhelming backlog of unmet need for 



20 

health services, these people view research as a Jure to divert people 
and funds from the real and urgent social problems of our times. 

Again, I would argue that as a nation v. : e can and must support 
both research and service. Furthermore , a career in research is no 
less noble a vocation than one committed to service. The $2.5 billion 
annual outlay for research and development is small compared with our 
total national health expenditures of more than $55 billion, and even 
the complete abolition of all research activity would only increase the 
funds available for service by 5 percent. 

I perceive a certain irony in the fact that some of those most 

deeply committed to stamping out disease seem prone to overlook the 

enormous mass of disease which no amount of presently available money 

or intelligence could modify. And here, perhaps, lies the root of 

the growing disenchantment with research. In the last couple of 

centuries, but particularly in the last few decades, science has been 

successful to an absolutely incredible degree, and as a consequence 

has revolutionized human existence. Dr. Lee DuBridge, appointed by 

President Nixon to direct the Office of Science and Technology, recently 

commented on this phenomenon in testimony before the Subcommittee on 

Science Research and Development of the House Committee on Science 

and Astronautics: 

Our success in the search for knowledge and in applying it 
[he said] has far exceeded the wildest dreams of our fathers 
and mothers. But we want more- -much more. We can conquer 



21 



sonic diseases; why not all? V.'c can fly to Europe in a few 
hours; why can't Ave get to the airport more quickly? The 
world could grov; many times as much food as it needs; why 
is there still hunger? We have built a vast educational 
system that -most of the world envies; why can't we make it 
still better adapted to match our new needs and our new 
ideals. 



This description suggests that we have conditioned ourselves, as 
a people, to expectations that increase not linearly but exponentially. 
And by the same token, we have rendered ourselves highly susceptible 
to frustration and disenchantment. The National Cancer Institute, 
since 193S, has indeed spent nearly $2 billion for research and research 
resources. But cancer- -and for that matter, atherosclerosis, aging, 
and schizophrenia- -remain formidable and terrifying medical problems. 
In the light of the dearth of cures to date, what course is more likely 
to yield solutions to these problems: a decrease or increase in future 
investments? 

I have tried to review for you who stand on or just over the 
threshold of careers in biomedical science some of the political, 
economic and social dimensions of the universe of research. In the 
United States today, research is predominantly a public rather than 
a private enterprise. Its rise and fall are therefore strongly dependent 
upon the processes and institutional forms of the Federal sector. 
Biomedical research is performed principally in Academe and is supported 
primarily by the National Institutes of Health to the extent permitted 
by the Department of Health, Education, and Welfare, the Bureau of the 
Budget, the President, and the Congress of the United States. 



2.2 



Biomedical research, like scientific research in general, has come 
upon hard times lately. It is less and less cherished, for a variety 
of reasons. But .this only serves to emphasize the need for its devotees 
to cultivate understanding, respect and support. Surely, this is a 
noble and worthy effort, for in the pursuit of knowledge resides man's 
best and only hope to move forward to a significantly higher plane of 
■health and well-being- -conditions requisite to the fullest expression 
and deepest realization of his freedom, his dignity, and his humanity. 



FOR THE RECORD: 

Dr. Thomas J. Kennedy gave a speech entitled "The Outlook for Careers in 
Biomedical Research" at the 1969 SAMA-UTB National Student Research Forum 
on April 24, 1969 in Galveston, Texas. The following slides were used: 

Slide 

O rder Title 

1 Medical Research as a Proportion of all 

Research and Development, 1968 Est. 

2 U.S. Medical Research and Development 

as a Proportion of Total U.S. Research 
and Development, FY 50-68 

3 Sources of Medical Research Funds, 

49,54,59,64,69 

4 Federal Medical Research as a Proportion 

of Total U.S. Medical Research, FY 47-68 

5 National Supoort for Medical Research, 

1948-1968 

6 Funds Obligated for Medical and Health- 
Related Research, U.S. —1959 Est. 

7 Federal Suoport for Medical Research, 

FY 48-68 

8 NIH Growth arid Functions, Consolidated 

Appropriations, FY 55-69 

9 NIH Appropriations, FY 1969 

10 Heart Disease, Fund Allocation, FY 67 

11 Cancer, Fund Allocation, FY 67 

12 How a Research Grant is Made 

13 NIH Grants and Othjrr Awards by Type of 

Award, FY 1968 

14 NIH Budget Process 

15 New Budget Authority, Fiscal 1969 



•#— 



Slide 

Order Title 

16 DHEW Budget Authority— FY 1970 

17 The Electron Microscope 

18 Development of the Oral Contraceptive 



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U.S. Medical Research and Development as p. Pro- 
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Fiscal Years 1950-6C . 



Fiscal year 



Total U.S. 
research and 

development 



U.S. medical 
research and 
development • 



1950 

1951 

1952 

1953 

1954 

1955 

195G 

1957 

1953 

195 f ' 

19G0 

1961 

I9G2 

19G3 

1964 

1905 

19SG 

19G7 est.. 

1950 est.. 



Millions of dollars 



2,900 
3,400 
3, 800 
5, 1G0 
5, 6G0 
6,200 
8, 370 
9,810 
10,810 
12,430 
13,620 
14,380 
15,610 
17,350 
19, 1G0 
20,470 
22,220 
23,800 
25,000 



Medical 

research and 

development 

as a percent 

of total R. & D. 

(percent) 



161 
175 

197 

214 

237 

2G1 

312 

410 

513 

648 

845 

1,045 

1,290 

1,486 

1,652 

1,841 

2,057 

2,280 

2,490 



5.6 
5. 1 
5.2 
4. 1 
4.2 
4.2 
3.7 
4.5 
5.0 
5.2 
6.2 
7.3 
8.3 
8.6 
8.6 
9.0 
9.3 
9.6 
10.0 



Excludes research training and constru-tion. 



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Federal Medical Research cs a Proportion of Tolnl 
U.S. Medic::! Research, Fiscal Years 19'J-GS » 



Fiscal year 


Total U.S. 
medical 
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Total 
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Total 
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Federal as 

a percent 

of total 

U.G. 
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research 




Mit'.ons of dollars 


(percent) 


1947 

1948 

1949 

1950 

1951 

1952 

1953 

1954 

1955 

1956 

1957 

1958 

1950 


87 

124 

147 

161 

175 

197 

214 

237 

261 

312 

440 

513 

618 

E45 

1,045 

1,290 

1,486 

1.C52 

1, 841 
- 2,057 

2, 280 
2,490 


27 

50 

65 

73 

85 

10? 

107 

119 

139 

162 

229 

279 

351 

448 

574 

782 

919 

1,019 

1, 174 

1,316 

1,453 

1,601 


CO 

74 

82 

88 

90 

94 

107 

118 

122 

150 

211 

204 

297 

397 

471 

503 

557 

C03 

667 

741 

822 

889 


31.0 
40.3 
44.2 
45.3 
40. C 
52.3 
50.0 
50.2 
53.3 
51.9 
52.0 
51.4 
54.2 


1950 

1961 

1952 

1963 

1954 

1965 

1956 

1957 

1968 


53.0 
54. 9 
60.6 
61.8 
63.5 
63.8 
64. 
63.9 
64.3 



' Excludes cxpcnclituics for activities such as training or 
capital outlays for research facilities. 



o 






Source of lunii 



Total 



NATIONAL SUPPORT TOR MEDICAL RESEARCH, 1943- 1968* 
(Obligiilic-ns in mi! lionc) 



1943 



124 



1953 



214 



1V5S 



1963 



1964 



1963 



1966 



196'/ cs! 



1,4:,6 1,652 1.E41 2,067 . 2,210 



1963 est. 



■//-.:' 



Government 
Fcdcrcl 
Stole onJ local 



50 


. 103 


292 


50 


107 


279 


n.o. 


1 


13 



964 

919 

46 



1.099 

1.049 

50 



1,229 

1,174 

55 



1,377 

1,316 

61 



1.523 

1.45S 
65 



1.670 
1,601 

69 



Industry 



43 



53 



Privotc support 


31 


43 


Foundations end health egi-ncios 


19 


26 


Other privotc contributors 


n.o. 


n.o. 


Endo'.vrv.snt 


12 


15 


Institutions' ov/n funds 


n.o. 


7 



170 

81 
45 
6 
19 
11 



375 

147 
85 
21 
19 
22 



400 

153 
83 
22 

19 

24 



450 

162 
92 
25 
19 
26 



511 

169 
94 

2c 
19 
23 



550 

V/7 

100 

29 

19 

29 



C'.'j 

iro 

101 
30 
19 

30 



•Covers only medicol end health-related research; such activities os rctecrch training end construction o: 
Beginning with 1962. data for nan-Fcderat components hove teen improved end o-e n^t strictly compere 1 .' 



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1.601 


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24.3 


37 


13.3 


55 


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7.5 


90 


6.8 


96 6.6 


97 


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3 


6.0 


6 


5.6 


14 


5.0 


53 


5.5 


43 


3.4 


45 


3.4 


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3.9 


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31 


11.1 


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9.6 


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114 


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43.9 


183 


6S.i 


6:5 


65.9 


636 


70.4 


935 


70.3 


l.O.'.O 73.0 


1,165 


72.6 


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(17) 


(34.0) 


(33) 


(35.5) 


(160) 


(57.3) 


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3.6 


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NEW BUDGET AUTHORITY, FISCAL. 1869 

(From JanuEry budget, in billions of dollars) 

• 

1. National defense $ 82.3 

2. Relatively uncontrollable. civilum programs, opon-crided 
programs, and fixed costs: 

Social Security, medicare, and other social insurance 

trust funds 45. 1 

Interest 14.4 

Civilian and military pay increase 1.6 

Veterans pensions, compensation, and benefits 6.4 

Public assistance giants 5.8 

Farm price supports (Commodity Credit Corporation) 3.4 

Postal operations .3 

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Other 3.5 

Subtotal, defense and relatively uncontrollable civilian 

programs . ; 163.2 

3. Relatively controllable civilian programs 43.6 

4. Undistributed in'cregovernmenta! payments ( — ) -5.0 

Total, new budcc-l authority proposed, 1969 201.7 







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National Expenditures for Biomedical Research* 



Robert W. Berliner, M.D.,\ and Thomas J. Kennedy, M.D.J 



The Council of Academic Societies has 
taken an important and constructive step 
in deciding to study the problem of the 
appropriate level for the nation's invest- 
ment in biomedical research. Speaking for 
the NIH, we certainly wish them well in 
this effort and look forward to further 
discussions in the development of ideas 
concerning this extremely difficult issue. 

Background 

A brief review of the history of the sup- 
port of biomedical research over the last 
three decades will lend some perspective. 
World War II provided the impetus for 
a heavy national investment in biomedical 
research. Prior to the early 1940's, research 
played a minor role, at least in the budget- 
ing of academic institutions; the scale was 
small, and the goals were defined by the 
individual faculty member. Total national 
expenditures for medical research were 
approximately §45 million, of which S3 
million were derived from Federal 
sources, $25 million from — and consumed 
by — industry, SI 2 million from founda- 
tions and voluntary health agencies, and 
$5 million from endowments. The success 



* Presented by Dr. Berliner before the Council 
of Academic Societies, Association of American 
Medical Colleges, Chicago, Illinois, February 6, 
1970. 

f Deputy Director for Science, National Insti- 
tutes of Health, U. S- Department of Health, Educa- 
tion, and Welfare. " 

| Associate Director for Program Planning and 
Evaluation, NIH, DHEW. 



of research in solving major problems inti- 
mately connected with the war effort — 
including but not limited to medical and 
health problems — facilitated post-war 
public investments in science and tech- 
nology. Research activities in all sectors — 
academic, industrial, and governmental— 
began to expand; research became profes- 
sionalized; and the patronage and spon- 
sorship patterns began to shift. The 
following data are illustrative: 

1. Table 1 reflects the growth in na- 
tional expenditures for research and, the 
larger element, development. They rose 
from $2.9 billion in FY 1950 to roughly 
S27 billion for FY 1970. Biomedical re- 
search increased from $160 million in FY 
1950 to nearly S2.7 billion in FY 1970. 
Over these two decades the percentage of 
the total devoted to medical research al- 
most doubled, from 5.6 to 9.8 percent. 

2. Table 2 depicts the pattern of growth 
in Federal financial support of biomedical 
research. By 1947 the total national invest- 
ment had almost doubled (from $45 
million to S87 million), accounted for 
principally by an expansion in the role of 
the Federal Government, a carry-over 
from war-time traditions and precedents. 
Since 1947 the investments in medical re- 
search and development by both the 
Federal and non-Federal sectors have ex- 
panded significantly. The annual Federal 
investment is now about SI. 7 billion, rep- 
resenting 62 percent of the biomedical 
research expenditures of the Nation. 



666 



cc 



Expenditures for Biomedical Research/ Berliner and Kennedy 



667 



( 

V 



TABLE 1 
U.S. Medical Research as a Pro- 
portion of All R&D, 1950-1970 
(Dollars in millions) 



Fiscal Year 



Total R&D 



Medical 
R&D 



Percent 



1950 


2.900 


161 


5.6 


1955 


6,279 


261 


4.2 


1960 


13,730 


845 


6.2 


1965 


20,449 


1,837 


9.0 


1966 


22,285 


2,053 


9.2 


1967 


23,680 


2,266 


9.6 


1968 


25,330 


2,440 


9.6 


1969 est. 


26,250 


2,595 


9.9 


1970 est. 


27,250 


2,660 


9.8 



3. Figure 1 shows a graphic summary 
of the sources of funds for biomedical re- 
search. While not shown in this figure, the 
rates of growth in the investments of 
industry and state governments have been 
roughly equivalent to those of the Federal 
Government, but the private sector's con- 
tributions have been increasing less 
rapidly. 

4. A more detailed analysis of Federal 
sponsorship (Table 3) shows that the 
DHEW is the major supporter of biomedi- 



cal research. In the late forties, the Atomic 
Energy Commission and the Department 
of Defense played major roles, contribut- 
ing respectively twenty-six and fourteen 
percent of the total Federal support. Cur- 
rently, each of these two agencies and the 
National Aeronautics and Space Adminis- 
tration account for six to seven percent of 
the Federal sponsorship. The DHEW 
share is attributable principally to the 

TABLE 2 

Federal Medical Research Support 

as a Proportion of All Medical 

R&D, 1940-1970 

(Dollars in millions) 



Fiscal Year 



1940 
1947 
1950 
1955 
1960 
1965 
1966 
1967 
1968 

1969 est. 

1970 est. 



Total 
Medical 



Federal 
Medical 



Nonfed. 
Medical 



45 

87 

161 

261 

845 

1,837 

2,053 

2,266 

2,440 

2,595 

2.660 



3 
27 

73 
139 
448 
1,174 
1,316 
1,459 
1,571 
1,656 
1,652 



42 

60 

88 

122 

397 

663 

737 

807 

869 

939 

1,008 



Percent 



6.6 
31.0 

45.3 
53 . 3 
53.0 
63.9 

64.1 
64.4 
64.4 
63.8 
62.1 



MILLIONS 
$ 2000 — 











FEDERAL 
$1655 










i 










$1049 




'iNON-FEDERAL 








































OTHER 
$264 






J5 603 
















$65 582 


$119 $116 


$55i 










■™,$29" 






INDUSTRY 








$675 










1 


E 1 ' u 1 





1949 1954 1959 1964' 1969 EST " 

*NON-FE0ERAL DATA ARE NOT STRICTLY COMPARABLE WITH THOSE FOR PRIOR YEARS. AS COVERAGE HAS BEEN IMPROVED 

Figure 1 
Sources of medical research funds 1949-1969. 



668 Journal of Medical Education 



Vol. 45, September 1970 









TABLE 3 








Federal 


Support 


for Medical Research, FY 


1949-1969 


k 








(Dollars 


in millions 












1949 


1959 


1967 


1968 


1969 Est. 


Department 


Amoun 


Percent 


Amount 


Amount 


Amount 


Amount 


Percent 


Total 


$65 


100.0 


$351 


$1,459 


$1J71 


$1,656 


100.0 


AEC 


17 


26.2 


44 


96 


95 


98 


5.9 


Defense 


9 


13.8 


32 


118 


114 


118 


7.1 


DHEW 


31 


47.6 


238 


1,051 


1,128 


1,174 


70.9 


NIH 


(25) 


(38.5) 


(212) 


(812) 


(864) 


(890) 


(53.7) 


NASA 


— 


— 


— 


82 


109 


117 


7.1 


NSF 


— 


— 


8 


14 


21 


26 


1.6 


VA 


4 


6.2 


13 


45 


46 


50 


3.0 


Other 


4 


6.2 


16 


53 


58 


73 


4.4 



* Covers biomedical research (projects, resources and general support) 
but not training or construction. 



[ 



NIH (which included the National Insti- 
tute of Mental Health until 1967). 

Thus, the NIH accounts for about a 
third of all support for biomedical re- 
search. Of course, its role is larger if the 
focus is placed on academic research, 
since little of the industrial investment 
goes to academic institutions. If, in addi- 
tion, contributions to research training 
and of research training to the conduct of 
research itself are taken into considera- 
tion, the NIH role is larger yet. 

This perspective makes it clear that a 
very large part of the question related to 
the appropriate level of national invest- 
ment in biomedical research is a matter of 
the appropriate level of NIH investment. 
Since academic deliberations and recom- 
mendations are unlikely to influence signif- 
icantly either industry or the other com- 
ponents of the private sector, the identity 
of the universities' problem and NIH's in 
terms of actionability, is even closer. In 
view of this common concern, it may be of 
interest to review the processes by which 
the level of spending is established each 
year. 

The Budget Process 

Figure 2 is a flow chart of the steps in- 
volved in this process, which normally 



takes eighteen to twenty-one months to 
run its course. The route is tortuous. The 
first part of the cycle, which lasts approxi- 
mately one year, is a continuous effort on 
the part of each level in the Executive 
Branch to convince the next higher level 
of the reasonableness of its proposals and 
then to adjust to the limits imposed. 

The process thus entails convergence, 
with progressively damped oscillations, on 
some final figure between the initial pro- 
posals from below and the ceilings estab- 
lished by higher authority. 

The debate ends with the formal pre- 
sentation of the budget to the Congress. 
From that time, each Federal administra- 
tor must support the President's Budget, 
no matter how many errors and injustices 
he may feel have been wrought upon this 
program in the budgetary process. Chaos 
would ensue if a public administrator 
could with impunity defy his boss and 
plead his own special interests to the 
Congress and the public. 

In hearings before the Congressional 
appropriations committees, program di- 
rectors defend the requests of the Presi- 
dent. These committees rely not only on 
the administrators from the Federal 
agencies, but also on a wide spectrum of 
other experts, sometimes selected by the 



TEMBER 1970 



Expenditures for Biomedical Research/Berliner and Kennedy 



669 





9 

1 

9 

7) 

1 

6 



4 

irt) 



months to 
ortuous. The 
jasts approxi- 
jous effort on 
he Executive 
,' higher level 
roposals and 
lposed. 
convergence, 
dilations, on 
|e initial pro- 
'eilings estab- 

formal pre- 
he Congress. 
.1 administra- 
ent's Budget, 
and injustices 
;ht upon this 
rocess. Chaos 
administrator 
lis boss and 
:rests to the 

Congressional 
program di- 
of the Presi- 
i not only on 
the Federal 
; spectrum of 
lected by the 




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670 Journal of Medical Education 



Vol. 45, September 1970 



[ 



committees, sometimes self-selected. Non- 
governmental members of the biomedical 
research community have developed con- 
siderable skill and a strong tradition of 
placing before the Congress their critique 
of all or specific segments of the Pres- 
ident's Budget. 

When the House of Representatives and 
the Senate have each completed action on 
the President's Budget and reconciled any 
differences between the two chambers, the 
appropriation bill goes to the President 
for his signature. Following this, the 
agency submits its plan for apportioning 
the appropriated funds for use over the 
four quarters of the fiscal year — that is, if 
there are four quarters left when the 
appropriation is passed. This is reviewed 
by the Office of the Secretary and by the 
Bureau of the Budget; and as a result, 
there may be revisions in the plan, includ- 
ing withholding of authority to use some 
of the appropriated funds. This with- 
holding of authority to spend, or to use 
the technical term, the establishment of a 
reserve, is usually based on a judgment 
either that the particular sums involved 
cannot be effectively used or that their use 
would not be in accord with the 
President's policy. 

THE DECISION MAKING 

So much for process. What about the 
determinants of decisions? For the Presi- 
dent, the budget is the basic document 
that embodies the specific programs of the 
Administration and the intensity of effort, 
or at least of funding, to be devoted to 
these programs. The President's choice of 
programs, and particularly of program 
emphasis, reflects his interpretation of his 
election mandate, modulated by a contin- 
uing evaluation. within his own political 
philosophy of what is in the best interest 
of the nation. The budget is the blueprint 
of the President's programs. Advice on 



program comes from the Cabinet Officers 
he has chosen as his major advisors, from 
his own staff, from his confidants through- 
out the nation, from his party leaders in 
the Congress, and from the political tradi- 
tion he represents. The President must try 
to convert his broad election mandate into 
specific programs, realizing that continu- 
ity of power in his hands or his political 
party will depend heavily on the develop- 
ment of appropriate and popular pro- 
grams and their successful and acceptable 
implementation. 

Quantitative dilemmas relate to accu- 
rate forecasting of the electorate's atti- 
tudes on the balance between public and 
private investment and to appraisals of 
the probable effects of taxation and public 
spending policies on the economy of the 
nation and the world. For quantitative 
advice the President relies on a small, 
highly qualified staff of experts collectively 
known as the Bureau of the Budget. This 
generally very competent group exerts a 
strong influence throughout much of the 
budget process as well as in the ultimate 
obligation of funds. 

No President ever starts with a clean 
slate. He assumes leadership of an on- 
going enterprise that has traditions, in- 
flexibilities, and obligations that have been 
built up over the years. The magnitude of 
these — represented in Table 4 — is often 
surprising to the uninitiated. 

THE "UNCONTROLLABLES" 

1. Obligations for national defense are 
the largest single item in the budget. They 
are vast, continuing, and only moderately 
increased by such demands as those of the 
Vietnam War. They reflect the high price 
that this country pays for what is assumed 
to assure its security. These expenditures 
may be viewed as relatively fixed and un- 
controllable. 

2. A number of civilian programs re- 



J) 



EPTEMBER 1970 f Expenditures for Biomedical Research/ Berliner and Kennedy 



671 



abinet Officers 
advisors, from 
(dants through- 
iarty leaders in 

political tradi- 
isident must try 
n mandate into 
E that continu- 
ior his pohtical 
m the develop- 

popular pro- 
and acceptable 

•elate to accu- 
ectorate's atti- 
een public and 
appraisals of 
tion and public 
:onomy of the 
f>r quantitative 
s on a small, 
erts collectively 
e Budget. This 
group exerts a 
it much of the 
in the ultimate 

5 with a clean 
Ihip of an on- 
traditions, in- 
that have been 
e magnitude of 
ile 4 — is often 
I 



nal defense are 
e budget. They 
Inly moderately 
as those of the 
the high price 
vhat is assumed 
se expenditures 
y fixed and un- 

programs re- 



c 



TABLE 4 

New Budget Authority, Fiscal 1969 

(From January budget, in billions of dollars) 

1. National defense s823 

2. Relatively uncontrollable civilian 
programs, open-ended programs, and 
fixed costs: 

Social Security, medicare, and 
other social insurance trust 
funds 
Interest 

Civilian and military pay increase 
Veterans pensions, compensation, 

and benefits 
Public assistance grants 
Farm price supports (Commodity 

Credit Corporation) 
Postal operations 
Legislative and judiciary 
Other 



46.1 

14.4 

1.6 

5.4 
5.8 

3.4 
.3 
.4 

3.5 



In examining the determinants of the 
decisions of the operating agencies, we 
shall limit the scope of the discussion to 
biomedical research and specifically to the 
National Institutes of Health. Thus, we 
shall omit reference to N1H health man- 
power activities, and we shall not include 
the smaller program of the National 
Library of Medicine. Our object is to 
select the programs and their funding level 
that will best further the essential bio- 
medical research mission of the N1H. 



Subtotal, defense and relatively un- 
controllable civilian programs 163.2 
3 Relatively controllable civilian pro- 

43 .6 
grams 
4. Undistributed intragovernmental 

payments (— ) 



-5.0 



Total new budget authority pro- 

a iQftQ 201.7 

posed, 1969 



quire essentially mandatory expenditures. 
Expenditures from the social insurance 
trust funds are mandated by specific 
statutes. Payment of interest on the na- 
tional debt is not discretionary. Promises 
and commitments to veterans cannot be 
breached. Funding of a number of pro- 
grams in the domain of public assistance 
and farm price supports are governed by 
explicit formulae laid down in legislation. 

3 Thus, the total of the demands on the 
budget made by national defense and un- 
controllable civilian programs represented, 
in FY 1969 the last completed fiscal year, 
about eighty percent of the total budget. 

4 The residual twenty percent available 
for discretionary expenditure is the maxi- 
mum that the President can program to 
leave his personal imprint on the nation. 



THE NATIONAL INSTITUTES OF HEALTH : 
ITS MISSION 

It is important that everyone share a 
clear and unambiguous understanding of 
this mission. The usual definition of the 
mission of the NIH-to support basic and 
applied biomedical research— is dan- 
gerously incomplete, because it fails to 
identify the purpose to which Federal sup- 
port is directed. Research is an activity 
pursued out of many motives and pur- 
poses, with different ones assuming pri- 
macy in differing contexts. 

An investigator may be driven by his 
desire to achieve understanding and con- 
ceptual mastery, by the joy he experiences 
from success in solving problems; by his 
aspirations for fame and, usually some- 
what less, for fortune symbolized by the 
departmental chairmanship or the Nobel 
Prize- by the gratification that he derives 
from' discovery that alleviates human 
suffering and blunts the toll of disease. 

An academic institution fosters research 
for a number of reasons. The requirements 
of scholarship include the creation of new 
knowledge as well as the preservation and 
transmission of existing knowledge. The 
institutional image upon which recruit- 
ment and retention of scholars depends is 
highly colored by the research accom- 
plishments of the faculty. The conduct of 
research is the other side of the coin called 



o 



[ 



672 Journal of Medical Education 

graduate education — that is, research is 
the methodology of graduate education, 
at least in the physical and biological 
sciences. 

Federal funds expended for research by 
the NIH are not, as in the case of the 
National Science Foundation, for re- 
search as research. The NIH is not a 
science agency; it is a health agency. 
Science is the means, health the objective. 
Funds are appropriated to the NIH to 
conduct, support and coordinate research, 
to the extent that these activities are rele- 
vant to the maintenance of the health of 
the American people and to the causes, 
diagnosis, treatment and prevention of 
physical and mental diseases. 

The NIH has sought to invest in bio- 
medical research projects that will ad- 
vance its mission, whether or not the 
investigator or the institution was moved 
by the same muse as was the Government. 
The basic role of the National Advisory 
Councils is to assure the mission relevance 
of the scientifically meritorious projects 
supported. 

We might digress just a moment to re- 
act to an "outside" view of the mission of 
the NIH that has gained considerable 
currency — namely, that support from the 
Institutes and research Divisions of the 
NIH (the old NIH) was thinly disguised 
and backdoor support for medical educa- 
tion. When after World War II it appeared 
probable that continuing large-scale 
public support for medical research would 
materialize, a decision was reached, for a 
variety of reasons, to select, as an institu- 
tional base for the effort, the nation's 
graduate schools and, in particular, its 
medical schools. Research and develop- 
ment in the physical sciences and engineer- 
ing continue ta -depend primarily on in- 
dustrial performers. Aid to medical edu- 
cation per se was not a primary or major 
objective of the focusing of Federal re- 



Vol. 45, September 1970 

search support in medical schools. Cer- 
tainly this decision has resulted in a major 
expansion of the size of the faculties of 
medical schools (by scholars primarily 
dedicated to research), and the participa- 
tion of these scholars in the education of 
undergraduate students has enriched and 
extended the content of the curriculum. 
From the point of view of the research 
mission of the NIH, however, these must 
be regarded as second-order benefits, and 
major significance is attached to the 
enormous amount of new knowledge 
created in the last two decades and to the 
imaginative applications of new and exist- 
ing knowledge to the solution of pre- 
viously intractable problems of disease. 
Of course, the NIH also recognized, even 
before it assumed responsibility for health 
manpower, that the nation's medical 
schools are the source and site of its major 
research competence, and that mainte- 
nance of the health of those schools is 
essential to its mission. 

BUDGETARY RESULTS 

Returning to the budget process, the 
next two tables illustrate the product of 
that process: the President's 1971 budget 
for the NIH. One table reflects organiza- 
tional structure; the other, program activi- 
ties.* Table 5 presents, by organizational 
component, the level of actual obligations 
for the fiscal year ending on June 30, 1969, 
and the expected obligations for FY 1970 
and 1971, the latter based on the Presi- 
dent's requests. The 1971 President's 
Budget would provide a net increase of 
S66 million — 4.6 percent — in the operat- 
ing level for the entire NIH. It also reflects 
an increase of $93 million over the ad- 
justed 1970 appropriation. Of this, S62 










* The tables and related text update the authors' 
address of February 6. They represent estimated 
obligations for FY 1970 and 1971, following the 
passage of the DHEW appropriations for FY 1970. 



o 



TEMBER 1970 

chools. Cer- 

:d in a major 

: faculties of 

irs primarily 

he participa- 

education of 

enriched and 

: curriculum. 

i the research 

|-r, these must 

benefits, and 

:hed to the 

v knowledge 

les and to the 

lew and exist- 

ition of pre- 

|s of disease. 

ognized, even 

■lity for health 

ipn's medical 

jte of its major 

that mainte- 

ise schools is 



process, the 

■he product of 

5 1971 budget 

ects organiza- 

rogram activi- 

Drganizational 

lal obligations 

June 30, 1969, 

s for FY 1970 

on the Presi- 

1 President's 

et increase of 

in the operat- 

It also reflects 

over the ad- 

Of this, S62 

bdate the authors' 
ipresent estimated 
[71, following the 
lions for FY 1970. 



Q 



Expenditures for Biomedical Research/ Berliner and Kennedy 



673 



> 



NIH Budget: FY 



TABLE 5 
1969 Actual Obligations and FY 1970 and 
1971 Estimates 
(Dollars in millions) 





1969 


1970 est. 


1971 est. 


increase 


1969 = 


100 


NIH component 


actual 


oblig. 


oblig. 


1971/70 


1970 


1971 


Total 


$1,471 


SI, 450 


$1,516 


$66 


99 


103 


Institutes & research 














Divisions, Total 


1,003 


974 


1,036 


62 


97 


103 


NCI 


182 


181 


203 


21 


99 


112 


NHLI 


161 


161 


172 


11 


100 


106 


NIDR 


30 


29 


35 


6 


98 


117 


N1AMD 


141 


132 


132 


ii 


94 


94 


NINDS 


104 


96 


97 


1 


92 


93 


NIAID 


102 


98 


99 


1 


97 


98 


N1GMS 


160 


148 


148 





93 


93 


N1CHD 


71 


75 


93 


19 


105 


131 


NE1 


22 


24 


26 


2 


111 


119 


NIEHS 


18 


18 


20 


2 


99 


111 


DBS 


8 


8 


9 


1 


100 


113 


F1C 


4 


3 


3 





75 


75 



million is for the Institutes and research 
Divisions, including the following major 
increases for the research programs: (a) 
the National Cancer Institute, especially 
for viral carcinogenesis studies; (b) the 
National Institute of Child Health and 
Human Development, especially for the 
program on population and family plan- 
ning, (c) the National Heart and Lung 
Institute, especially for investigations re- 
lated to atherogenesis; (d) the National 
Institute of Dental Research, especially 
for work on caries; and (e) the National 
Institute of Environmental Health 
Sciences and the National Eye Institute to 
get their embryonic programs ofT the 
ground. The other four Institutes— Neu- 
rology and Stroke, Arthritis and Meta- 
bolic Diseases, Allergy and Infectious 
Diseases, and General Medical Sciences- 
will hold at about their 1970 levels, which 
are generally below those of 1969. 

Table 6 is organized by broad classes of 
program activity encompassing the entire 
NIH. An additional S15 million is re- 
quested for the regular research grant 
programs. Increases are also proposed for 



the specialized research centers and, to a 
lesser extent, for the general and categori- 
cal clinical research centers. These in- 
creases are offset by a twenty percent 
reduction in the funds requested for the 
general research support program. 

"Collaborative research and develop- 
ment" describes work usually undertaken 
at the initiative of the Government, gen- 
erally through research contracts, and 
frequently awarded to nonacademic per- 
formers. The very substantial increase of 
S40 million represents the emphasis on 
research in viral oncology and in family 
planning, population control, and contra- 
ceptive technology. These are areas in 
which academic institutions have much to 
contribute, and it is hoped that they will 
compete for the use of these funds. 

Funds for research fellowships are 
slightly reduced, while those for training 
grants are at approximately the same 
levels in FY 1970 and 1971. 

This is the budget that has been sub- 
mitted to Congress and will be defended 
by the NIH in its appropriation hearings 



o 



674 Journal of Medical Education 



Vol. 45, September 1970 



TABLE 6 

NIH Budget by Program Activities: FY 1969 Actual 

Obligations and FY 1970 and 1971 Estimates 

(Dollars in millions) 







1970 est. 




Increase 


Program activity 


1969 actual 


oblig. 


1971 est. oblig. 


1971/70 


Total 


t!, 471 


$1,450 


$1,516 


$66 


Regular research grant pro- 


460 


440 


455 


15 


grams 










Noncompeting 


309 


317 


322 


5 


Competing 


151 


123 


133 


10 


Special research grant pro- 


161 


151 


158 


1 


grams 










General research support 


53 


50 


40 


-10 


Categorical clinical re- 


11 


10 


11 


1 


search centers 










General clinical research 


35 


35 


38 


3 


centers 










Specialized research cen- 


14 


14 


21 


7 


ters 










Other 


48 


48 


48 





Collaborative R&D 


122 


127 


167 


40 


Research training programs 


201 


183 


182 


-1 


Fellowships 


55 


47 


45 


_ t 


Training grants 


146 


136 


137 


1 


All other programs 


527 


541 


553 


13 



[ 



this year. The decisions of the Congress, 
while formally "semi-final," usually pre- 
vail unless the President wishes to with- 
hold all or part of the Congressional 
increases. Thus, the political process is the 
final determinant of the level of national 
research investment. The task is, then, to 
provide a rational and logical framework 
for the political decision-makers to deter- 
mine what ideally should be spent on bio- 
medical research. 

Theoretical Bases 

for Aggregate Funding Level 

In the early 1960's, some unusually per- 
ceptive individuals, including Mr. William 
Carey of the Bureau of the Budget, began 
to foresee that the then current rate of 
growth of the nation's science budget 
could not long continue and began an 
intensive examination of the basic ques- 
tions now before this Council. There have 
been a number of illuminating contribu- 



tions, among which the reports to the 
House Committee on Science and Astro- 
nautics by the National Academy of 
Science entitled Basic Research and Na- 
tional Goals (1965) and Applied Science 
and Technological Progress (1967) stand 
out. It would seem worthwhile to mention 
a few of the ideas that have been offered 
and to discuss some of the problems their 
application presents. 

A number of papers take the position 
that research expenditures represent a 
necessary overhead if the larger activity to 
which they relate is to grow, stay modern, 
and avoid obsolescence. 

OVERHEAD ON THE GNP 

It has been argued that the research ex- 
penditures of a nation can be viewed as 
the necessary overhead for its national 
growth and development, and thus should 
be coupled to the Gross National Prod- 
uct. Tying the budget for research to the 



EPTEMBER 1970 



icrease 
171/70 

$66 
15 

5 

10 

I 

10 

1 





40 

-1 

-2 

1 

13 

reports to the 
j:nce and Astro- 
!1 Academy of 
{search and Na- 
4pplied Science 
is (1967) stand 
,hile to mention 
ive been offered 
: problems their 

ike the position 
es represent a 
arger activity to 

iw, stay modern, 



the research ex- 
in be viewed as 
[for its national 
and thus should 
National Prod- 
research to the 



(. 1 



Expenditures for Biomedical Research/ Berliner and Kennedy 



675 



TABLE 7 
Aggregate National Health Expenditures, by Type of Expenditure, Calendar 

Years 1929-68 

(Dollars in Billions) 



Type of expenditure 



1929 



1966 



1967 



196S 



Total $3 6 $4.0 $12.9 $27.0 $40.6 $45.1 $50.9 $57.1 

Health services and 3.4 3.8 11.9 25.1 36.8 41.1 46.7 52.4 

supplies , , 

Construction 0.2 0.1 0.8 1.0 1.9 2.0 2.0 2.3 

Research 0.05 0.2 0.8 1.8 2.1 2.3 2.4 



Research as a per- 
cent of total health 



1.3 



1.6 



3.0 



4.4 



4.7 



4.5 



4.2 



GNP has the virtue of proving compensa- 
tion for the rises in costs due to inflation 
as well as seeing that research keeps pace 
with the growth of the nation as a whole. 

OVERHEAD ON MEDICAL CARE EXPENDITURES 

For biomedicine, perhaps a more at- 
tractive and logical alternative is to relate 
medical research more directly to the 
universe it serves. Table 7 shows the na- 
tional expenditures for health over the last 
forty years. The citizens of this country 
spent fifty-seven billion dollars on health in 
1968; and if present trends continue, these 
costs will continue to expand. The bulk of 
the expenditures included in the total are 
for health services. Research, which is 
regarded by some as an investment in 
product improvement, by others as a 
deferred health service, constitutes a rela- 
tively small fraction of the total medical 
expenditure. Intuitively, it would appear 
to make some sense to consider research 
investments as an overhead on health care 
costs and to fix research at some reason- 
able fraction of the total cost of health. 
This approach has the merit of being 
more susceptible to a comparison of costs 
with benefits— for example, the costs that 
the health care system has been spared as 
a result of the development of viral vac- 
cines (as for polio, rubella, measles); in- 



novations in antibiotic chemotherapy 
(tuberculosis, syphilis); and the introduc- 
tion of psychoactive drugs. The benefits 
from these accomplishments alone exceed 
by far the total investment since 1940 in 
biomedical research. There is of course no 
guarantee that striking benefits will con- 
tinue, but it is a fairly safe assumption 
that they will. 

A particularly attractive aspect of this 
approach to determine the level of funding 
is that it discourages attempts at seeking 
"trade-offs" between medical care and 
medical research. It emphasizes that the 
great demands for medical services con- 
stitute a pressure for increased medical 
research rather than a reason for taking 
funds from medical research to meet the 
demands for care. It also underlines the 
great preponderance of care costs over 
research costs and makes clear how little 
any funds that might be taken from re- 
search would, in fact, bolster medical care. 
On the other hand, it encourages the 
fallacious reasoning that research expendi- 
tures should be proportional to the cost of 
the specific problem to be studied— the 
view that any problem can be solved if 
enough money is spent on it. In fact, the 
distribution of funds must be determined 
by an assessment of the scientific oppor- 
tunities, a determination as to which fields 



o 



676 Journal of Medical Education 



Vol. 45, September 1970 



are ripe for exploitation. The size of the 
expenditure for research on a particular 
problem should certainly be influenced by 
its importance, but this cannot be the sole, 
or even the primary, determinant. 

EXPLOITATION OF AVAILABLE MANPOWER 

Another possible method of determin- 
ing the level of research investment might 
be to set it at the level required to utilize 
the available manpower. Certainly, the 
availability of competent manpower sets a 
limit on the amount that can be effectively 
expended. In the long run, however, this 
method carries unacceptable elements of 
positive feed-back. If any level of man- 
power will be supported, there is pressure 
for excessive expansion of the manpower 
pool. 

Conversely, a determination to reduce 
expenditures for research can be effected 
by cutting off the supply through the 
training process. In the long run this 
method begs the question of the appro- 
priate level of research and is inherently 
unstable. 

PLANNED AND REGULAR GROWTH 

Dr. Harvey Brooks suggested several 
years ago that the country should commit 
itself to the goal of annually increasing its 
investments in research, development, and 
technology. In what he defined as "little 
science," he advocated that increases 
should be quantitatively sufficient to off- 
set price inflation, to support the increased 
costs attributable to increasing complexity 
of science — new instruments, computers, 
etc. — and finally to provide funds to ex- 
pand the level of program activity by ex- 
ploring new areas of science and intro- 
ducing new scientists into the system. The 
Brooks proposal has been a convenient 
whipping boy, since empirical support for 
the explicitly proposed exponent for 
growth is lacking. To the extent that 



Brooks suggested a national commitment 
to maintain the present level of program 
activity, there is no great problem. The 
difficulty is in determining the appropriate 
increment. 

COST-BENEFIT ECONOMICS 

In recent years, there has been an in- 
creasing effort to treat decisions about the 
level of research expenditures as an invest- 
ment problem and to try to evaluate 
which of all the possible marginal invest- 
ments of funds will produce the greatest 
(measurable) economic benefits to the 
investor. Thus, research advocates are 
asked to demonstrate the economic value 
of their proposals. Ideally, the value of 
the investment should be equivalent to the 
value of the return. If investment exceeds 
return, money has been wasted. If return 
exceeds investment, opportunities have 
not been exploited fully. 

This approach is beset with formidable 
conceptual and practical difficulties. How- 
might one assign an economic value to an 
advance in medical care that derives from 
medical research, even if the medical care 
result could be predicted before the re- 
search was done? For some parts of the 
result, one could estimate the costs 
avoided in reduced days of hospitaliza- 
tion, in reduced payments for physicians 
or drugs, and in additional days of em- 
ployment. Clearly, however, these are far 
from the total gains sought by society 
when it supports efforts to find new meas- 
ures for preserving health. How much do 
we assign for reduced pain, discomfort, 
deprivation? How much for a life saved? 
These are questions that could be ex- 
plored at great length; but when one has 
finished, he would still have no generally 
acceptable answer. The conclusion must 
be that there is no answer possible in the 
framework of economic investment 
theory; it is a matter of taste and judg- 



September 1970 

al commitment 

/el of program 

problem. The 

:he appropriate 



as been an in- 
sions about the 
-es as an invest- 
ry to evaluate 
narginal invest- 
ace the greatest 
benefits to the 

advocates are 
ijeconomic value 
y, the value of 
Equivalent to the 
jbstment exceeds 

asted. If return 
ortunities have 

with formidable 
■difficulties. How 
imic value to an 
hat derives from 
the medical care 
I before the re- 
me parts of the 
nate the costs 

of hospitaliza- 
s for physicians 
jbal days of em- 
'er, these are far 
ught by society 
» find new meas- 
.. How much do 
ain, discomfort, 
for a life saved? 
at could be ex- 
ut when one has 
:ave no generally 
conclusion must 
er possible in the 
pic investment 

taste and judg- 



Expenditures for Biomedical Research/ Berliner and Kennedy 



611 



ment. We spend what we can afford within 
the limits of what respected scientific 
judgment predicts to be fruitful for the 
goals we seek. 

DISJOINTED OPPORTUNISTIC 
INCREMENTALISM 

Actually the level of NIH funding has 
been arrived at by what has been aptly 
called "disjointed opportunistic incre- 
mentalism"— a term apparently picked up 
from economist friends and introduced by 
Philip Handler. The NIH, like other 
components of the Federal Government, 
does not develop a new budget each year 
from a zero base. Since 1945 a complex 
system and network for the conduct of 
biomedical research has developed in the 
United States, and the Federal Govern- 
ment through the NIH is both a part of 
this system (through its inhouse labora- 
tories and clinics) and the major patron 
of it. To revalidate each component every 
year would be a monumental undertaking 
and one that would threaten the stability 
of the entire structure it supports. Instead, 
the annual budget formulation process 
enables the NIH to effect marginal 
changes in its components, and simul- 
taneously to continue its commitments to 
the mainstream of the national research 
effort. Even this limited intervention is 
not easy. The NIH presently support: 
about 11,000 research grants requiring 
about S600 million annually, about 
16,000 trainees under research training 
grants requiring SI 36 million; and about 
4,500 fellowships and career development 
awards requiring about $47 million. 

Obviously this universe is too large for 
central decisions on individual items. The 
first level at which detailed judgments are 
reached is in the -Institutes. These must try 
to determine the fiscal requirements to 
continue productive existing commit- 
ments, to phase out unproductive work 



in orderly fashion, to make new commit- 
ments that exploit scientific opportunity 
emerging from research progress, and to 
modulate all proposals in view of the 
limitations of trained manpower, facilities, 
and other necessary resources. 

Although this situation has been ar- 
rived at without preconceived plan and 
without precise ties to any particular 
system for setting its level, it should not 
be dismissed out of hand. Lacking any 
particular way of deciding the appro- 
priate absolute level for research, one 
might as well select something of the 
order of magnitude that now exists— one 
that does provide the research environ- 
ment essential to our institutions of 
higher education, that utilizes the talents 
of the majority of those with high levels of 
training and capacity in the field, and that 
provides the capacity for self-renewal in 
the education and training of young 
people. It is important, of course, that the 
base not be eroded by inflation. In par- 
ticular, the increments should include 
developmental efforts. Although these 
need not be built permanently into the 
base, the large sums of money that they 
require should not be allocated at the 
expense of that base, essentially one of 
fundamental biomedical science. 



Criteria for Decisions on Allocation 

Whether an aggregate total level of ex- 
penditures for biomedical research is 
arrived at from "above" by an "over- 
head" type of estimate, or from "below" 
by "disjointed incrementalism" the devel- 
opment of a detailed expenditure plan 
must eventually depend upon allocation 
decisions. In the domain of biomedical 
research, the questions related to criteria 
applied for allocation of funds must be 
addressed. These become progressively 
more undefinable in operational form as 
the stage of action enlarges. To decide the 



■~> 



678 Journal of Medical Education 



Vol. 45, September 1970 



[ 



relative importance of health science, 
nuclear science, physical science, or social 
science is part of the overall problem. The 
calculus for establishing relative priorities 
for health, education, welfare, urban 
renewal, national defense, urban trans- 
portation, conservation, recreation is 
another. What is more determinative: the 
probability of success or the importance 
of the problem? How are these related? 

In reality, however imperfect the deci- 
sion-making theory, decisions must be 
reached if the existing system is to con- 
tinue. A vast amount of soul-searching 
goes into every annual Federal budget 
cycle in which such choices are regularly 
made. 

The problem has two major dimensions 



— technical and political. The technical 
aspects are complex and difficult. Yet it is 
impossible to evade the responsibility of 
developing the most logical, rational, and 
objective evidence to support proposals to 
invest public funds in biomedical research. 
The final judgment depends on how much 
the people of the nation wish to pay for a 
research program in absolute terms, as 
well as in relation to the other social 
benefits in which they can invest. A sound 
political decision will not be made until 
the average citizen or his representative 
understands certain elements: the issues 
and problems of disease; the cost of 
establishing, maintaining, and expanding 
an effective research apparatus; and the 
probability of solutions to the problems 
with and without a research effort. 



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X 

FEDERAL BUDGETS FOR MEDICAL R&D, FY 1970-1972 
(in millions) 



Agency 


1970 
actual 


1971 1972 
est. obligations 


Increase 
1972/71 


Percent 
increase 


Total 


$1,664 


iL 


,930 $2,078 


$148 


8 


VA 


59 




62 62 


- 





DoD 


125 




117 115 


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-2 


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105 104 


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103 78 


-25 


-24 


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28 




30 32 


2 


7 


1,177 


i 


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123 


9 


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(i 


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(128) 


(12) 


Agriculture 


50 




55 56 


1 


2 


Environmental 
Protection Age 


:ncy 




85 100 


15 


18 


Other 


35 




52 87 


35 


67 



V For FY 1971 and FY 1972, excludes those research programs transferred 
to the Environmental Protection Agency, December 1970 

Note: Covers support of medical and health-related R&D (projects, re- 
sources, and general support) but not training or construction 



HISTORY OF THE HEALTH PROFESSIONS EDUCATIONAL ASSISTAIiCE ACTS 



. TJK-ADPpr 
1969-12*" 



Year of 

Enactment Programs Authorized 



1963 



Construction of Teaching 
Facilities 



Student Loans 



1964 Student Loans 
PL 88-654 



1965 Basic and Special Iir.prove- 
PL 89-290 ment Grants 

Scholarships 



Student Loans 



1966 Construction 
PL 89-709 

Student Loans 



Eligible Professions 



196S Construction of Multipurpose 
PL 90-490 Facilities 



Institutional Grants 



Special Project Grants 



Scholarships 

Study of Adequacy of Programs 
-Report by July 1, 19/0 



Medicine, Dentistry, Osteopathy, 
Pharmacy , Podiatry, O ptometry , 
Nursing or Public Health 

Medicine, Dentistry, Osteopathy 



O ptometry 



Medicine, Dentistry, Osteopathy, 
Optometr y, Podiatr y 

Medicine, Dentistry, Osteopathy, 
Optometry , Podiatry , Pharmacy - 
Pharmacy, Podiatry 



Veterinary Medicine 
Veterinary Medicine 



Medicine, Dentistry, Osteopathy, 
Optometry, Podiatry, Pharmacy, 
Veterinary Medicine 

Medicine, Dentistry, Osteopathy; 
Optometry, Podiatry, Piiarrnacy 
Veterinary Medicine 

Medicine, Dentistry, Osteopathy, 
Optometry, Podiatry, Pharmacy 
Veterinary Medicine 

Vet erinary Medicine 

All Professions 



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THE CURRENT YEAR (FISCAL YEAR 1971) BUDGET 



(In thousands) 

- F . Y . Fi scal Year 1971 Changes Over 1970 

1970 President's Congr. 1971 Co1ur.fi of 

Activity Actual Budget Approp. 1972 Budget* 

' Institutes & Research Divisions 

Researcn grams $592,689 +$15,030 +$79,821 +$70,603 

Training grants & fellowships 155,971** -1,732 +10,730 - +3,289 

Collet), res. (mostly contracts) 127, C38 +43,072 +53,384 +58,823 

Intramural research 90,302 +9,539 +13,401 +13,551 

Other direct operations 46,471 +2,850 +3,423 +3,823 

Subtotal, IRD's 1,012,521 +68,759 +165,759 +150,094 

Bureau of Health Manpower Educ. 
Medical, cental ana related 

health professions 301,257"* -2,120 +35,640 +35,640 

Nursing 50,444 +15,000 +24,500 +24,500 

Public health l/,r70 -995 +505 -t-5 05 

Allied health 13,330 +6,106 +6,105 ■ +6,105 

Prog. dir. h. manpower anal .. . 4,809 +350 +350 +350 

Other . ... 13,515 -5,738 -5,733 -5,733 

Subtotal, BHME 401,375 +12,603 +61,363 +61,363 

National Library of Medicine ... 19,979 +302 +1,302 +1,302 

Other 10,058 +7,3 07 +7,307 +7,307 

Total, NIH 1,443,933 +88,971* + 235,731 + 220.056 

♦Reflects pay increases and decreases for funds held in budgetary reserve." 

♦♦Reflects comparative transfer of $23,000,000 for the salary components of 
research training grants in health professions schools from the Institutes 
to the Bureau of Health Manpower Education. 



NIK-ALPPE 
2-25-71 



THE PRESIDENT'S 1972 BUDGET 

(In Thousands) 
1971 Column 1972 

Activity - Comparable Estimate Change 

Institutes and Research Divisions 

Research grants $663,292 $680,516 +$17,224 

Training grants and fellowships 159,250* 152,679* -6,581 

Collaborative res. (mostly contracts) 185,916 189,814 +3,898 

Intramural research 103,853 109,009 +5,156 

Other direct operations 50,294 51,291 +997 

Special cancer initiatives -- 1 00,030 +100,000 

Subtota';, IRD's T7T62,615 17233,309 +120,694 

B ureau of Health Manpower Education 
Medical, cental ana related 

health professions 336,897* 421,5*8* +84,651 

Nursing .. 74,944 68,013 .-6,925 

Public health 18,475 18,514 +39 

Allied health ." 19,436 26,494 +7,003 

Program direction & manpower anal... 5,159 6,227 +1,068 

Other 7,777 7,015 -762 

Subtotal, BHME 462,738 547,816 +35,073 

National Library of Medicine 21,281 21,486 +205 

Other 1 7,365 -17,803 __ ^38 

Total,. NIH ' 1,663,999 1 ,870.414 +206.415 

♦Reflects a comparative transfer in each year of $23,000,000 from the 

Institutes to the Bureau of Health Manpower Education for the salary 
components of research training grants awarded to health professions 
schools. 



KIH-ADPPE 
2-25-71 



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r,zr, ,r:': 1970 - 63 



DISTRIBUTION OF PRIVATE AND PUBLIC HEALTH EXPENDITURES 

BY TYPE OF EXPENDITURE 

FISCAL YEAR 1970 



542.3 biiiion 




d ki • /State SI 
Publ ic,( ■, , 
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Fiscal year 1970 



ADPPE-NIH 
2/71 



FEF.D ? UP 



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rri > TJX - Adpp: 

r.zr. ,c: :■*.■: 1970 - 63 



DISTRIBUTION OF PRIVATE AND PUBLIC HEALTH EXPENDITURES 

BY TYPE OF EXPENDITURE 

FISCAL YEAR 1970 



$42.3 biliion 




Fiscal year 19SG 



Pub! ic 




Fiscal year 1970 



ADPPE-NIH 
2/71 



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DISTRIBUTION OF PRIVATE AND PUBLIC HEALTH EXPENDITURES 
BY TYPE OF EXPENDITURE 
FISCAL YEAR 1970 



Private Expenditures 



Public Expenditures 



Construction 




Construction 



*»/ Nursing Home 
Drugs and Appliances 7 Car6 

1S% 




Drugs and 

Appliances 

2% 



Total $42.3 billion 



Total $25.0 billion 



ADPPE-NIH 
2/71" 



THE MISSION OF N I H 
TO ftMICE HEALTH AND VflJL-BEIKG THROUGH SUPPORT OF- 



o RESEARCH 0) to provide a eetter product for the health care system 

TO DELIVER 

(2) TO RED'JCE COSTS THROUGH DEFINITIVE SOLUTION OF HEALTH 

PROBLEMS 

C TATVnZR TO OPERATE THE HEALTH-CARE DELIVERY SYSTEM 

o IliSTITlTO to sustain the f;.::lities for producing knowledge 

AND MANPOWER 

o CQtL^ICATICvIS to provide the operators of the health-care delivery 
system with rapid access to needed information 



■J 



Sources of Support for Medical Schools 
(in thousands) 

1958-59 1967-68 1968-69 

$ % $ % $ % 

Sponsored Programs 

Federal Contracts and 
Grants for Teaching, 
Service, Research and 
Training 94,900 30 544,745 46 633,304 45 

(NIH) (94,000) (29) (501,165) (43; (587,826) (43) 

State and Local Government 
Contracts and Grants 
for Research 2,855 1 13,135 1 12,101 1 

Other Non-Federal 

Support 46,483 15 127,328 11 145,138 11 

Regular Operating Program s 

Indirect Costs on Federal 
Contracts and Grants 

Tuition and Fees 

State Appropriations 

Unrestricted Endowment 
Income 

All Other 



TOTAL 



- 




74,452 


6 


83,863 


6 


24,368 


7 


48,252 


4 


51,968 


4 


49,779 


15 


142,946 


12 


169,531 


13 


17,577 


6 


29,618 


3 


31,991 


2 


83,067 


26 


195,788 


17 


238,158 


17 


319,029 




1,176,264 




1,366,054 





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DHEW OBLIGATIONS TO MEDICAL SCHOOLS, BY AGENCY, 1969 



,/iillions 
$800- 



600 



400 



200 



$588 




NIH 



SRS 



PERCENT 

Other DHEW 




£ I "2 



$139 




HSMHA 



$770 Million 




SRS 



$7 



\ i t • > * > f n 



Other 
DHEW 



ORA-OAOPPE-NIH 
December 1970 



MEMORANDUM FOR THE RECORD : February 25, 1971 

The following material was used by this office to prepare Vugrafs and 
Xerox copies for Dr. Kennedy's presentation at the AD HOC Advisory Group 
on Simulation Models, Feb. 25, 1971 at the Linden Hill. Title of meeting: 
"The Role of the NIH in Fostering the Application of Systems Analysis to 
Academic Medical Centers." Nickname "ORA Meeting." Meeting to continue 
thru Feb. 26, 1971. (Note: Sue Fremeau has the originals.) 

Title Source 

DHEW Obligations to Medical Schools, Publication "DHEW Obligations 
by Agency and Program, 1969 (Table) to Medical Schools, FY 

67-69" produced by ORA. 

DHEW Obligations to Medical Schools, 
by Program, 1969 (Table) 

Obligations for Research as a 
Proportion of Total DHEW SupDort 
to Medical Schools, 1967 & 1969 
(Chart) 

DHEW Obligations to Medical Schools 
for Supoort of Research, 1947 & 
1967-1969 

Distribution of DHEW Support to 
Medical Schools by Aqency, 1967 
& 1969 (Chart) 

3 Pie Chart on Service, Research & Special Projects 3ranch 
Education 

NIH Obligations to Medical Schools Publication "DHEW Obligations 
as a Proportion of Total DHEW to Medical Schools, FY 

Support, 1969 (Chart) 67-69" produced by ORA. 

DHEW Obligations to Medical Schools, 
by Agency, 1969 (Chart) " 

DHEW Obligations to Medical Schools, 
by State, 1969 (Chart) 

SEE ATTACHED 



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DHE4 OBLIGATIONS TO MEDICAL SCHOOLS, 
BY PROGRAM, 1969 



Type of support 



Amount 
(millions) 



Percent 
distribution 



Total 

Research 

R&D conduct 

R&D plant 
Training (graduate and 
postdoctoral) 

Training grants 

Fellowships 
Undergraduate training 
grants & scholarships 
Construction J 
General science support 
Other 



$ 770.4 



100. 



361.5 


47.0 


355.7 


46.2 


5.8 


0.8 


162.1 


21.0 


125.3 


16.3 


36.8 


4.8 


11.3 


1.2 


93.4 


12.1 


28.6 


3.7 


113.4 


14.7 



J/ Teaching and related facilities 



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DHEW OBLIGATIONS TO MEDICAL SCHOOLS FOR SUPPORT OF RESEARCH 

1947 AND 1967-1969 



Millions 
$400 r— 



300 



200 



100 



$356 



$2 




1947 



1967 



968 



969 



ORA-OADPPE-NIH 
December 1970 



DISTRIBUTION OF DHEW SUPPORT TO MEDICAL SCHOOLS BY AGENCY, 

1967 AND 1969 



Percent 
100- 



80- 



60- 




OTHER DHEW Percent 

■A /.O/N 100 



40- S 



20-: 



SRS (5%) 



OTHER PHS 
(26%) 






NIH (69%) 



riff 



1967 



80- 



60- 



40- 



20 



/OTHER DHEW 
^ (1%) 



76% 



-NLM (.5%) 



W>. BHME 
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SRS (5%) 



OTHER PHS 
(18%) 



institutes:; 

^Divisions:; 
i(50%)S 



NIH (76%) 



969 



ORA-OADPPE-NIH 
December 1970 



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DHEW OBLIGATIONS TO MEDICAL SCHOOLS, BY AGENCY, 1969 



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$800 



PERCENT 



600 



400 



200 



0- 



$588 




Other DHEW 





$770 Million 



$37 




$7 



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SRS 



Other 
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ORA-OAOPPE-NIH 
December 1970 



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KAY 13 1971 



ACADEMIC SCIENCE SUPPORT PROGRAMS 
OF THE NATIONAL INSTITUTES OF HEALTH* 

Thomas J. Kennedy, Jr., M.D. 



To provide a background for the discussion on the contribution of the 
National Institutes of Health to the support of academic science, I should 
like first to sketch very briefly the main features of recent trends in Federal 
support to academic institutions. For this purpose I shall make use of 
transparencies which I believe will convey quickly and clearly the points 
I wish to make. 
Growth of Federal Support to Academic Institutions, 1963-1967 

Between 1963 and 1967 Federal obligations for both science and non-science 
purposes increased rapidly -- from $1.4 billion to more than $3.0 biilion 
(ILLUSTRATION 1). These five years witnessed major changes in Federal 
programs, reflecting the impact of new legislation as well as expansion and 
improvement of existing programs. 

Several forces influences this growth — 

o An increased demand for higher education; 

o The emergence of a national consensus on the acceptance 
of a new Federal role in higher education; 

o The proliferation of new social programs in the mid-19 60' s; and 

o Strong Presidential encouragement of academic science. 



* Presented before the Advisory Committee for Planning, 
National Science Foundation, May 14, 1971. 



/ 



- 2 - 

The Apparent End of Expansion, 1967-1970 

The rapid rate of growth which characterized this period did not, however, 
continue into the last years of the decade. Beginning with 1967, fiscal 
constraints imposed by the Vietnam War, Executive efforts to curb inflation, 
and shifting program priorities resulted in a levelling-off in the rate of growth 
of Federal obligations to academic institutions. Indeed, between 1969-70 
Federal support actually declined by almost $260 million — from a peak level 
of $3.5 billion in 1969 to about $3.2 billion in 1970. 

Federal Support of Academic Science 

Academic science (indicated by the heavy curve) also experienced a 
period of relatively rapid growth between 1963-1967 with Federal obligations 
for this purpose rising from $1.3 billion to $2.3 billion. Since 1967, however, 
support for science has reflected the total Federal pattern of decelerated 
growth and — most recently — of moderate decline. Yet, it is important to 
note that these developments have been attended by an expansion in support 
s\ from other sources, notably State governments. (Taking into account all 
jj> sources of financial support, total expenditures for academic science increased 
Y x 7 and 3.5 percent, respectively, between 1968-69 and 1969-70.) 

And as you are aware, the President's Budget for FY 1972 proposes signi- 
ficant increases for academic science. Later, I shall have occasion to refer 
/ to the implications of this budget request for NIH and its programs of academic 
support. 



- 3 - 



Growth of Non-Science Activities 

I should perhaps point out that since 19 64 the rate of growth of the 
non-science component of academic support has significantly exceeded that 
of academic sciences (ILLUSTRATION 2). Particular striking increases for 
these activities occurred in the four years, 1964-1967; thereafter, non-science 
programs encountered the same budgetary constraints which had inhibited the 
growth of academic science. 

As shown, the pattern of growth of non-science support has clearly 
paralleled the growth of OE funding of higher education activities. Much of 
the increase indicated for the Office of Education in 1964-66 was due to the 
implementation of the Higher Education Act of 1963 which assigned to that 
agency responsibility for aiding in the construction of new undergraduate 
and graduate facilities. 

The Agency Sources 

ILLUSTRATION 3 emphasizes the prominent role of the Department of 
Health, Education, and Welfare as a prime source of financial support to 
academic institutions. In all, seven cabinet departments and five other 
agencies obligate appreciable amounts, although only two departments 
(DHEW, DOD) and one agency (NSF) administer programs totalling $200 million 
or more per year. 



/• 



- 4 - 



The emergence of DHEW over the past decade as the primary source 
of support to academic institutions has been due principally to the 
expansion of the Department's activities in health fields (largely through 
programs of NIH) and in higher education (through OE). The rather striking 
increase in DHEW support during 1964-19 67 (ILLUSTRATION 4) is primarily 
attributable to the swift growth in magnitude and diversity of OE programs 
under legislation enacted by the 88th and 89th Congresses. 

Through its multi-faceted programs of academic support, the Department 
has contributed to the strengthening of the Nation's structure for higher 
education and to the building of a broadly-based, vigorous, and world-renowned 
national system for biomedical research. 

THE NIH POSITION 
The National Institutes of Health occupies a special position as the 
largest single source of support to academic institutions (ILLUSTRATION 5) . 
This agency now accounts for half of the DHEW total and a third of all 
Federal support at academic institutions. In FY 1970 NIH contributed over 
$1 billion* .for research, training, construction, and general support of 
operations. Through the magnitude and scope of its operations in the academic 



* Includes non-science activities. 



- 5 - 



setting, NIH has become the principal determinant in the making of medical 
research policy and exercises a powerful influence on the realization of 
the Nation's health goals. 

Fiscal History of NIH Programs, 1960-1970 

The growth of NIH over the past decade is re fleeted in its budget 
history (ILLUSTRATION 6). May I quickly run through the stub-entries of 
interest: Extramural program obligations, which constitute a comprehensive 
measure of current operating support to grantee institutions and long-range 
capital investment in both people (through training grants and fellowships) 
and in space (through research facilities construction grants); obligations 
for academic science , including research, training, and facilities awards 
to academic institutions; and as a subset of these, awards to medical schools 
by the Institutes and Research Divisions of NIH, and the combined NIK/NIMH 
data for 1960-1969. 

In ILLUSTRATION 7 the major elements have been selected and 
normalized to reflect FY 1960 = 100. The general patterns of growth are 
discernible here: steady and positive growth for most program categories 
through 1967-68 and a levelling or decrease thereafter. Program levels for 
1970 do notdiffer materially from those recorded for 1967. 



- 6 - 



The chart (ILLUSTRATION 8) depicts this pattern graphically. 1968 is 
shown to be the peak year for the total NIH extramural programs, with 
research accounting for three-quarters of the total. Particularly evident 
is the rise and fall of the research facilities construction program which 
exhibited steady growth through 1965 and a precipitate decline thereafter. 

i 

i 
The Impact of Inflation 

In ILLUSTRATION 9 the total growth in program expenditures has 

been further refined through application of the GNP deflator to cover simple 

/ price inflation. The data presented here clearly identify some of the 

major causes for concern in the biomedical community. While the total 

budget for extramural research, measured in current dollars, has 

levelled off , the actual amount of research, measured in constant dollars, 

has declined since 1968. Similarly, support for academic science has 

also dropped in real terms -- from $600 million in 1968 to $495 million 

in 1970 (although a moderate increase is anticipated for 1971). 

The course of real program levels are reflected in the following 

table and chart (ILLUSTRATIONS 10 and 11) where constant dollars have 

been normalized to FY 1960. As shown in ILLUSTRATION 11, real growth 

in (1) medical school academic science support, and (2) academic science, 

outpaced growth of the NIH extramural programs and the total NIH budget. 



- 7 - 



Other inflationary factors beyond those reflected in simple GNP 
deflator have been: differentially high faculty salary growth (in part 
a consequence of more rapid escalation of professional income of 
practicing physicians), growth in hospitalization costs, and increasing 

complexity and sophistication of instrumentation and equipment 

i 
(ILLUSTRATIONS lla-lle) . 

In consequence of the deceleration of real growth in agency support, 
the academic community has been experiencing considerable difficulty 
in absorbing the effects without disruptions of a major nature. Although 
the impact has varied with individual institutions, it has been estimated 
that constraints on Federal spending coupled with general inflation and 
other special factors have resulted in a 25 percent reduction in the 
program level of biomedical research since the funding peak of 1967-68. 

The Institutes of NIH 

The relative emphasis of NIH categorical program support may be 
deduced from current appropriations data of individual institutes and the 
President's 1972 budget (ILLUSTRATION 12). 



- 8 - 



A total of $1.2 billion was appropriated in FY 19 71 for NIH Institutes 

and Research Divisions. These funds support a wide diversity of 

research and training activities aimed at disease categories and the 

promotion of health. The most heavily funded programs include cancer, 

heart, general medical sciences, arthritis, allergy, and neurology.' 

Major increases for the 1970-72 period are reflected in the appropriations 

of (a) the National Cancer Institute, especially for viral carcinogenesis 

studies and the separately budgeted Cancer Initiative; (b) the Heart 

and Lung Institute, especially for investigations related to atherogenesis ; 

(c) the National Institute of Child Health and Human Development, especially 

for the program on population and family planning; (d) the National Institute 

of Dental Research, especially for work on caries; and (e) the National 

Eye Institute and the National Institute of Environmental Health Sciences 

to get their embryonic programs off the ground. 

— . . > 

ILLUSTRATION 12A identifies the specific areas of program emphasis. 

Beyond the special initiative areas I have just mentioned — cancer, 

chil&TTealth, dental health, environmental health, heart disease — are 

the continuing basic programs in allergy and infectious diseases, arthritis 

and metabolic diseases, neurological diseases and stroke, and the general 

medical sciences. 

/ - * 

!,■;'■'■'-' "■ ' v '-' ~- ■'■ r t - ■'... .- 2 '. 

Ct *\.d h^l £j -f) ->' ' - :■ C'f "{' r&? < .'V i, - ± C / u f>" '-».-' If.ZLt-.'t'r-':'* 



- 9 - 



Of paramount importance, however, is the special, targeted 
attack on cancer announced by President Nixon in his State of the Union 
message last January, and elaborated in his public statement on Tuesday. 
The "Cancer-Cure Program", as presently envisaged, will remain in the 
National Institutes of Health but will be independently funded and operate 
under a director who will report directly to the President. Much of the 
actual research will be performed extramurally, under contract, at 
academic institutions and at other research facilities throughout the 
Nation. 

The broad classes of program activity are summarized in ILLUSTRATION 
13. I shall only take a moment to highlight the significant changes: 
Indicated is a substantial increase of $88 million for the research grants 
program between 1970-72; funds for fellowships are slightly reduced, 
while those for training grants are at approximately the same level in 
FY 1970 and 1972. Collaborative R&D, a subset of "Direct Operations", 
describes work usually undertaken at the initiative of the Government, 
generally through research contracts, and frequently awarded to non- 
academic performers. The very substantial increase of $63 million 
between 1970-72 represents the emphasis on research in viral oncology 



- 10 - 



and in family planning, population control, and contraceptive technology. 
These are areas in which academic institutions have much to contribute, 
and it is hoped that they will compete for use of these funds. 

For NIH as a whole, the President's FY 1972 Budget provides 
an increase of nearly $450 million over the FY 1970 level. This 
increase has presented NIH with unusual opportunities and unusual 
problems. Among the questions now being explored are — 

o The effect on the balance of NIH's overall mission 

of the relatively uneven distribution of the budget increases; 

o The probable distribution of the additional funds among 
grantee institutions; and 

o The impact of the increases on the institutions and 
their activities. 

MEDICAL SCHOOLS 
Most of these funds are, of course, expended in the academic setting, 
and NIH support at academic institutions continues to be broadly based 
and pervasive. In 1970 NIH awarded funds to almost 600 colleges and 
universities throughout the Nation, as a means of discharging its 
health missions. 



- 11 - 



Included in its programs of academic support are all of the Nation's 
existing medical schools, as well as 12 medical schools in development. 
And here perhaps I should pause to say a few words about the critical 
role of NIH and DHEW in support of the Nation's medical schools. These 
institutions represent an appreciable fraction of total Federal funds 
obligated at colleges and universities — almost a fourth; the DHEW 
contribution now accounts for well over nine-tenths of the Federal total 
and constitutes more than half of the medical schools' total expenditures.* 

Research and Training 

Research continues to comprise the largest single segment of DHEW 
support to medical schools, accounting for almost half the total 
(ILLUSTRATION 14). However, support for research has exhibited a somewhat 
uneven pattern of growth in the last four years, dipping in 1968 below the 
level reported for the previous year, and dropping again in 1970 below the 
level reported for 1969. This pattern reflects a more general tendency 
characteristic of the growth of total Federal R&D support in the recent 
period. 



* Estimate based on annual accounting of medical schools to 
AAMC and the AMA Council on Medical Education. Data do not 
include total medical center outlays, e.g., hospitals. 



<fe 



- 12 - 



As shown, DHEW obligations for training purposes increased 
gradually between 1967-1970. Recently, efforts have been underway to 
assess the impact of these programs. A National Academy of Sciences 
study of training programs sponsored by the National Institute of 
General Medical Sciences was concluded in 1969, and an intensive 
agency review covering basic aspects of the program is now in progress. 

Expanding Health Resources 

Support for research and training, of course, accounts for the larger 

part of the NIH extramural program — as it has for the past two decades. 

The last few years, however, have witnessed a shifting emphasis of 

these 
agency support away from/' traditional" support categories to other, newer 

programs. For example, NIH efforts in 1967-1970 were increasingly aimed 

at the problem of augmenting national health care resources — primarily 

physician manpower — and in improving arrangements for delivery of health 

care (ILLUSTRATION 15). These programs include financial aid to medical 

schools and other health professional schools for construction of teaching 

facilities, direct support for institutional operating costs, and limited 

undergraduate aid through scholarships and loans to low-income students. 



- 13 - 



The Current Plight of Medical Schools 

Despite moderate growth of overall DHEW support to medical schools 
in recent years, more than half these schools are now experiencing severe 
financial difficulties; many have applied for and have received interim 
assistance — "distress grants", if you will — from the Department. 
Retrenchment appears to be an immediate prospect for many schools, and 
a few institutions have indicated the possibility of discontinuing operations 
altogether. 

Numerous factors have contributed to this unfortunate situation 
— declining endowment income, increasing graduate enrollments, leveling 
of support for research, burgeoning costs of MEDICARE and MEDICAID, 
student disorders, and, in some instances, unfavorable actions of State 
legislatures. 

I cannot tell you now how long this period of uncertainty will last. 
Clearly, a prolonged projection of the current situation would threaten all 
our major national health objectives. 

CHANGES AND TENDENCIES 
(ILLUSTRATION 16) For the remainder of the time alloted to me I 
should like to consider, very briefly, some of the changes and tendencies 
of recent years and a few of the problems and issues which concern us at 

NIH. 



- 14 - 



/ 



Organizational Changes 

For NIH and DHEW the past few years have been a period of 
reorganization and consolidation. Under the reorganizations of 1968 
(ILLUSTRATION 17) the former Bureau of Health Manpower and the National 
Library of Medicine were incorporated into the National Institutes of Health; 
two new agencies — the Health Services and Mental Health Administration 
and the Consumer Protection and Environmental Health Service were created, 
combining all other functions assigned to the Public Health Service 
(segments of CPEHS have recently been incorporated into the newly organized 
Environmental Protection Agency). Of particular significance for NIH was 
the broadening of its responsibilities to embrace activities relating to 
medical education and training, responsibilities now centered in the Bureau 
of Health Manpower Education (BHME). In short, as a result of this 
organizational change, our mandate now involves support of education as 
well as research. 

Shifting Emphasis to Health Services 

(RETURN TO ILLUSTRATION 16). A second important tendency which 
has affected our thinking and planning has been the new national interest 
and emphasis accorded the health services. For the next few years the 



- 15 - 



problem of marked concern about our whole health service system will 
inevitably complicate the picture of support for academic science. 
Medical schools are deeply involved, not only as producers of manpower, 
but because their teaching hospitals also constitute the main source of 
biomedical research. 

The new emphasis on health care has already resulted in a 
fundamental shift in the distribution of the health dollar (ILLUSTRATION 18 ) . 
Ten years ago roughly two- thirds of the Federal health dollar was devoted 
to medical research and research training; about a tenth was spent on 
personal health services for the general population. In 1970 health 
service funding rose to about 60 percent of the Federal total. Health 
service financing programs have been the fastest growing segment of the 
Federal health dollar. 

Strengthening Academic Science 

(RETURN TO ILLUSTRATION 16) . Support for academic science will 
continue to have a high priority in the currant administration, as indicated 
by the President's Budget for 1972. This budget proposes significant 
increases in research funds to colleges and universities — between 
9 and 12 percent — more than compensatory for the year's inflat.on. 



/ 



- 16 - 



These increases will be subsidized by the Administration's new 
expansionary full-employment budgetary policy. 

t 

Targeted Programs 

Of increasing importance, too, has been the highly-targeted program 
approach to research problems, particularly in areas of cancer, heart, 
dental health, child health, family planning, and population studies. 
(ILLUSTRATION 19). I have already mentioned President Nixon's unequivocal 
affirmation of a total national commitment to the conquest of cancer 
and in the Legislative Branch, action is pending on Senator Kennedy's 
"Conquest of Cancer Act" (S. 34) which provides for transfer of employees, 
•contracts, property, and resources from the NCI, a component of NIH, to 
a National Cancer Authority. 

Approximately 38 percent of the project contract activity budgeted for 
1972 is expected to be performed in the academic setting; however, an 
increasing share -- 40 percent in FY 1972 contrasted with 37 percent in 1971 — 
will be performed in industrial laboratories. 

A New View of Training 

(RETURN TO ILLUSTRATION 16) In regard to the question of training we 
anticipate that in the future greater use will be made of the resources of the 
private credit market to assist individuals and institutions in meeting heavy 
one-time costs which can be repaid over a period of years. This approach 
will receive Federal backing through appropriate guarantees and subsidies. 



•- 17 - 



And although I can affirm that NIH is still in the training grant 
business, I must add that. we have not been without a sense of 
harassment in regard to this program for the past several months. 
Indeed, since April of last year, a searching study of NIH training 
programs has been underway in response to a request of the Office of 
Management and Budget. A preliminary report has been submitted 
delineating what is necessarily a complex situation. Additional 
evidence is now being sought to illuminate the whole question of 
training in the biomedical sciences. It seems almost certain, however, 
that NIH will continue to rely heavily on the training grant as the most 
effective support mechanism in meeting biomedical research manpower 
needs for the future. 

PROBLEMS AND ISSUES 
In passing, let me mention only a few of the problems and issues 
which have drawn our attention in recent months and which, I believe, 
confront all of us involved in science planning (ILLUSTRATION 20). 

Uncertainty of Curraai Situation 

The current situation is characterized by continuing fiscal 
instability at many of the Nation's academic institutions, aggravated 
by inflation; constraints on Federal funding of academic science 
activities; growing competition for available resources generated by 



- 18 - 



unresolved social, ecological, and other issues; and in the field of 
health the prospect of drastic reorganization of the entire health 
service system. 

Current Difficulties in Long-Range Planning 

This framework of uncertainty is necessarily inimical to the 
long-range planning effort. It is difficult to plan under circumstances 
where even the most fundamental questions are raised regarding the 
appropriate relationship of Government and universities, and of the 
proper role of science in American life. 

Nor does there appear to be any consensus on basic issues such 
as the need for additional scientists and engineers. Health manpower 
planning, for example, is fairly difficult when no agreement exists on 
the question of whether there are at present too many or too few 
physicians or biomedical investigators. We are responsible for the 
intermediate product, but the final goal — the number of physicians 
required at a finite point in time — is unknown. 



- 13 - 



Pluralism vs. Centralization 

One of the issues to which a vast amount of attention has been given 
is the perennial one of the centralization of science: the need to 
reconcile the virtues of a diversity of sources of Federal support and 
multiplicity of programs with the growing necessity for central policy 
direction and control of Federal programs within the Executive Branch. 
Decentralization and pluralism in Federal science are blamed for the 
chronic weakness of science planning and program coordination in the 
Federal system; the objection to centralization has been the fear that 
poor judgment or bias could foreclose the chances of support for some 
investigators. 

NIRAS 

A related issue has been the proposal to establish a National Institute 
of Research and Advanced Studies. As you are aware, considerable 
discussion has attended the proposal to create NIRAS — the new 
administrative entity recommended by the Daddario subcommittee last April. 
Such an agency would include an institute of natural sciences, an institute 
of education, and an institute of arts, humanities, and social studies. 
As presently envisaged, it would operate with a budget of more than 
$2 billion and would be responsible for funding as much as 60- percent 
of all Federally supported research. 



\ 

20 - 



In accordance with the recommendations of the Committee additional 
study is now being given to the status of the National Institutes of Health 
in respect to NIRAS. The fact that NIH is essentially a research activity 
lends weight to the argument for its inclusion in NIRAS; the fact that NIH 
research is so pointedly a mission-oriented type of research favors the 
argument against its inclusion. Proponents of NIRAS have not faced the 
real issue of what distortions would be created in a so-called balanced 
program by a Manhattan project in cancer or in environmental pollution. 

Federal Responsibility for Higher Education 

Turning our attention for a moment from science and research to 
education, we find that in recent years there has been increasing support 
for the adoption of a policy to define the financial responsibility of the 
Federal Government for higher education. There appears to be general 
agreement that the educational institutions of the Nation are in serious 
financial straits. The question is what-form this assistance shall take -- 
whether to the institutions or to the students, whether the support should 
be restricted to the sciences or opened to the arts and humanities, and 
whether it should be. in the form of loans or grants. 



- 21 - 



The New Federalism 

Looking ahead, we are witnessing the evolution of a basic 
realignment of Federal-State-local relations. New concepts of 
revenue -sharing and welfare reform have been proposed which, If 
implemented, could have a profound impact on educational financing. 

THE TASK AHEAD 

The immediate and urgent problem before us, however, is how best 
to manage the present resources in a period of constrained budgets and at 
the same time to strengthen the science environment and assure the con- 
tinued growth and development of the Nation's academic institutions. 

Within the limits of statutory authority and fiscal capability, the 
National Institutes of Health will continue to seek ways and means to 
improve the effectiveness of existing programs; to provide more stable 
mechanisms of support; and to reinforce the general capabilities of 
academic institutions to deal with the iricreasing challenges and 
responsibilities thrust upon them by society. 



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NIH OBLIGATIONS FOR SELECTED BUDGET CATEGORIES, 1960-1970 
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Medical school 
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Total extramural 
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1960 



62 



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68 



70 



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Growth of ^capitalization Costs 1955-1970 
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KJ1 



ADPPE Revised 
:5-19-71 



DR. KENNEDY'S SPEECH 
IN DEDICATION' OF THE PRIMATE BUILDING 
MAY 20, 1971 

It is a pleasure to welcome all of you to this dedication of our new 

Quarantine 
Primate/Building at the NIH Animal Center. The activities to be carried 

out therewill play an important role in the support of our research 
piograms. On this occasion it seems particularly appropriate to con- 
sider some of the ways iri *hich primates and other animals play a vital 
role in biomedical science. 

More than 50 million animals are used annually in research in the 
United States. The National Institutes of Health alone uses about one 
million laboratory animals per year at its Bethesda laboratories and 
three million in its Cancer Chemotherapy Program. In addition, approxi- 
mately 57 percent of the 12,000 research grants currently supported by 
NIH are dependent on the use of animals. There is no doubt that studies 
involving animals have been indispensable to the virtual eradication of 
polio, undulant fever, the nutritional deficiency diseases, and other 
scourges of yesterday, and to the great strides that have been made 
against diabetes, tuberculosis, and the insect-borne febrile infections. 
Complex surgical procedures such as the corrective operations for congenital 
heart disease, artery and organ transplantations, and refinements in orthcoe; 
surgery were also based -en animal =xperiment3. 

As a result of these and ether successes, as well as the advance 
in knowledge of animal and human physiology, scientists have increased 
their reliance upon animals in research. Laboratory animals are not 



< - 2 

only used in greater numbers, but their quality and definition has become 
greatly refined. As capabilities increased and instruments became more 
precise and sophisticated, there was need for more uniform and specially 
bred stocks. 

The field of comparative medicine is by no means new. In American 
research institutions, laboratory animals have been used since the 1850's. 
The field developed at a rather slow pace, and funds for the support of 
animal facilities and activities usually received a low priority. Little 
attention was given in the early days to the animals' environmental or 
nutritional requirements, nor to their naturally occurring diseases. 
Laboratory animal medicine was far from sophisticated, and a great deal 
of development was needed before it could support research as we know it 
today. 

In the 1920' s, more attention was given to the study of laboratory 
animal diseases and colony management, and a few excellent animal colonies 
vere developed. Still, the field really did not begin to move toward its 
present-day capability until after the Second World War. Today, I believe 
that everyone in the field of biomedical research recognizes the impor- 
tance of high-quality, well-defined animals of known characteristics 
to support their studies. It is also recognized that such animals are 
only to be had through the efforts of well-trained professionals working 
vith the proper equipment in adequate facilities. Through the extramural 
and intramural activities of SIH, programs have been initiated to meet 
some of these needs. 

Extramurally , NIH established and continues to support the Regional 
Frimate Research Center Program. From this evolved support of other 



< ' 3 

types of animal resources in biomedical research institutions. Post- 
doctoral training programs are conducted for the preparation of specialists 

f 

in laboratory animal medicine and care. Grants have been made for the 
development of specific animal models, the study of laboratory animal 
diseases, and the acquisition of more basic data on environmental 
factors affecting these animals. 

With NIH support and encouragement, the Institute of Laboratory 

Animal Resources of the NAS/NRC prepared the Guide for Laboratory Animal 
Facilities and Care . More than 75,000 copies of the Guide have been 

distributed since the first edition was published in 1963. Its reception 

in the scientific community has been very favorable. As stated in the 

preface to the third edition: "The primary purpose of the Guide continues 

to be to assist scientific institutions in providing professionally 

impropriate care for laboratory animals. The recommendations are based 

on scientific principles and on expert opinion and experience with methods 

eTid practices that have proved to be consistent with high quality care." 

The NIH intramural programs have also provided leadership in the 
field of laboratory animal development. Early in these efforts, infor- 
mation was gained about the control and elimination of diseases that 
could affect various laboratory animals. Many genetic strains with unique 
heritable characteristics were developed, and techniques for the large- 
scale production of gemfree and pathogen-free animals were employed. 
Methods of animal experimentation were improved. Viable programs' have 
continually evolved "to meet the needs of our Institutes and research 
Id. vis ions . 

As the major Federal biomedical, research organization, NIH must 
also play a special role in the support of certain national requirements. 



For example, NIH workers have developed special genetic strains and have 
maintained these and other strains developed elsewhere. Currently we 
have more than 65 strains of rodents exhibiting a wide variety of 
susceptibilities, pathologic conditions, or unique physiologic traits 
useful in biomedical research. NIH serves as an international source of 
these animals for the establishment of new breeding colonies and as a 

recognized source of reference stocks. 

kept 
What we have here is unique; it must be preserved and/available as 

a national resource. Ways to meet this responsibility even better than 

in the past are being explored. For example, it was recently observed 

that some of the guinea pigs in our colonies are deficient in C-4 

complement, a characteristic that makes them exceedingly valuable in 

certain types of immunology research. A small breeding colony of these 

animals has been established, primarily to meet our own needs, but we 

hope eventually to make breeding stock available to the entire biomedical 

research community. 

Along this line, there is need for the further recognition and 

development of animal models for biomedical research. It has become 

apparent that most human disease problems have counterparts in the 

animal world — counterparts that must be sought where they have not yet 

been recognized. Toward this end, we need a closer union of physicians, 

veterinarians, and other biologists. Once such models have been developed, 

they must be adapted to the laboratory and disseminated to those who 

need them for their research. The recent successes in studying kuru in 

chimpanzees and squirrel monkeys, and the viral production of lymphocytic 

leukemia and malignant lymphoma in owl monkeys, demonstrate the potential 

for new models to study slow viruses and cancer viruses. 



5 

NIH workers have also organized programs to conserve laboratory 
animals., A canine blood donor colony was established to eliminate the 
need to sacrifice dogs in order to prime heart-lung machines in experi- 
mental surgery. This greatly reduces the number of dogs used each year. 
We also save animals by developing better methods for their nutrition, 
care, and disease control. The recently inaugurated Animal Disease 
Investigation Service makes available to our 1,200 intramural investigator 
the clinical and diagnostic services of veterinarians and other pro- 
fessionals in the. control and elimination of animal disease problems. 

Nonhuman primates have played an important role in NIH's research 
programs. Currently, our intramural investigators are using more than 
9,000 of these animals. Approximately 2,500 are housed here in Bethesda 
and the remainder in contractors' facilities. Primates have been the key 
to testing of polio vaccines and have been important in studies of 
infectious diseases, neurological conditions, perinatal physiology, and 
behaviour. Their importance in cancer research and surgical studies 
is growing. 

Primates, of course, require special consideration because of the 
difficulties in their maintenance and the fact that many of them are 
imported from the wild and carry diseases that can be hazardous for man 
and for other animals. It is standard procedure here at NIH for all of 
the primates to be brought into a central facility for quarantine and 
conditioning before they are sent to various research laboratories. This 
program will continue in the new building we are dedicating today. The 
transfer of this operation to Poolesville will afford an opportunity to 
provide a central primate holding facility here in Bethesda. Previously 



6 

the NIH investigator who wanted to try something new in primates either 
had to develop the space in his own Institute or use a contractor's 
facility. There was no provision for the use of small numbers of animals 
to conduct pilot studies. This will now be possible. 

We are also looking ahead to new needs in the primate field. It is 
becoming increasingly evident that NIH must provide for the breeding 
of primates. Many investigations require the availability of animals 
with timed pregnancies, and other studies require neonates of known age 

» 

and medical history. Most importantly, primates may not always be readily 
available from the wild; there are indications that their supply may be 
decreased by population pressures in some of the source areas. We foresee 
the day when the primate building will be used more and more for breeding 
and perhaps less and less for quarantine. These observations, of course, 
are not new to most of you in this audience: but I want to bring out 
the fact that many people at NIH are cognizant of these problems and are 
giving them attention. 

For the dedication of this building, we felt that it would be 
appropriate to bring together members of the scientific community with 
a particular interest in primates. Further, we wanted to have a symposium 
that would provide a common ground for such a group. Although the subject 
is an old one, tuberculosis in primates still poses many challenging 
questions, and there is an opportunity to dispel much misinformation and 
misunderstanding. 

Certainly, almost everyone who works with primates has a common 
interest in this problem. Recently, in our own facilities, we experienced 
an outbreak of tuberculosis its a laboratory that housed 75 primates on 



t ' 7 

a long-term study. Many of these animals had been born and bred in 
captivity, but somehow tuberculosis had entered the colony. The disease 

i 

spread rapidly, and approximately one-quarter of the colony had to be 
eliminated. The investigator calculated that several of these animals 
had up to $50,000 worth of research time and effort invested in them. 
These are some of our reasons for choosing the topic "Dealing with 
Tuberculosis in Primate Colonies." 

We feel confident that information disseminated here will be useful 
to the entire biomedical research community, providing a clearer under- 
standing of this disease and its control. It will also help in the 
recognition of areas that need further investigation. With these 
objectives in mind, let us proceed with this symposium, which will serve 
as the dedication of our new Primate Building. 



CO 
CD 



/ 






COMMENTS CX THE PAPER OF DR. IVAN L. BENNETT 
ENTITLED ''SUPPORT OP RESEARCH AND GRADUATE EDUCATION IN THE UNITED STATES" 



Delivered in the Seminars en Science and Public Policy 
at Rockefeller University 
December 9, 1371 

Thomas J. Kennedy Jr, M.D. 



It's always a difficult task to add anything to one of Drl Dennett's 
typically masterful presentations or to contribute new insights to 
those already laid before you by the distinguished prior speakers in 
this series of seminars. In reading the manuscripts and ruminating 
about them, however, it seemed to me that events of the last few years, 
particularly the leveling of Federal expenditures for R&D, have had one 
big positive dividend: the call for analysis, reflection and assessment 
that is both timely and promising. At the moment, thinking on the subject 
seems to be in the "mugwump" stage, in part dominated by traditional 
values and simultaneously reflecting the enormous transformation wrought 
during the last three decades in the role of science in society. 

Looked at in perspective, the several quantum leaps in the magni- 
tude of the science enterprise. since about 1940 may be viewed as a sharp 
discontinuity with a long tradition of basic stability courled to slow 
growth. In many ways, the world of science has only incompletely ex- 
plored and perhaps only partially experienced the consequences of its 
new estate. A forum such as Dr. Shannon has organized will surely lead 
to a better digestion and integration of the changes and illuminate the 
direction for a new synthesis for the governance of science in the nation. 

A couple of the dimensions of the transformation that seem particu- 
larly important to me relate to size and to Federal support: 

o Size, as measured by any number of surrogates — funds expended, 
numbers of people engaged, scope of concern, expansion in 
plant — has created many unprecedented conditions. Among other 
■ , things, the income requirements of performing institutions have 
increased to levels unimaginable even a generation ago and 
converted academic officials such as deans into a breed that 
must bear all of the heavy burdens — without any of the generous 
rewards — of Wall Street financers. 

e Federal dependency has awakened performers and performing 

institutions to a new and painful appreciation of the Federal 
budgetary process with all of its formal discipline as well as 
with the host of undisciplinable forces and pressures from 
countless publics and constituancies which impinge upon and 
influence it. The Federal Budget each year announces to the 
Congress the political platform of the President of the United 
States; when the opposite party controls the Congress, the 



-I- 



judget message is a guantlet. In it the President 
reflects his own. best judgment of how to carry out his electicr. 
mandate, how best, to balance ail of the contending and conflicting 
aspirations of a diverse and pleuralistic society. The President's 
assessments are annually subject to micro variations in emphasis, 
determined by gentle winds of shifting public taste. But they 
must also reflect macro changes, precipitated by major and often 
unexpected reordering of national priorities. The Federal budgetary 
process may appear to the scientific and academic communities to 
be a bronco. Wishes of these groups to the contrary notwithstanding. 
I suspect the bronco will not be broken but will have to be 
ridden. There is evidence that skills for the latter task are 
resident in abundance within the scientific community. 

The issues yet to be resolved are whether or not some of the in- 
valuable traditions of yesteryears enterprise — far smaller and far more 
dependant on non-public funding — whether or not the traditions of a 
more courtly and genteel era can survive. 

The set of problems surrounding graduate training in the sciences 
illustrate many knotty aspects of the issue. Like Dr. Bennett, I too 
havp hppn dftpnlv immersed in this subject for the last couple of "ears 
and concur in his assessment that it presents many complex, challenging 
and researchable questions. Let me mention a few. Scientific research 
has been professionalized and — to introduce a term that thirty years ago 
would have been considered a barbarism — a research manpower labor market 
is casually discussed. Students undertake graduate education to qualify 
themselves for lifetime careers in research. Supply/demand considerations 
have emerged and conventional wisdom currently seems to accept the premise 
that labor market demand be measured and labor supply be regulated to 
minimize the difference between supply and demand. Students expect not 
to be led down primrose career paths, Federal Agencies expect that students 
trained at Agency expense use the training, and the Congress and general 
public look ascance at the spectacle of the talent of highly specialized 
manpower underutilized, especially when trained at public expense. 

In this context, how can universities retain autonomy, freedom, 
independence? How can they control their own graduate programs and 
graduate enrollments when there is a generally recognized need to con- 
certize — in the service of balancing supply and demand — for example, the 
activities of more than 150 universities which grant Ph.D. 's in the basic 
biomedical sciences? Can the universities confederate and cooperate on 
a problem like this? Can some be expected to volunteer to amputate an 
integral part of their programs? What processes in the event of no 
volunteers? These aspects of the governance problem were recently 
raised by Wolfle & Kidd, as Dr. Bennett noted. 



-3- 



Another issue related to graduate training is the phenomenon of 
ossillation. A tendency for this to occur might be expected from con- 
sideration of the lengthy period r.ruired for scientific training; 
unless a shortage or surplus of supply is foreseen well in advance 
and appropriate adjustments cade early in the number of people entering 
the training pipeline, overshoot will occur since the preexisting cut-° 
put level will be maintained for many years before the adjusted intake 
is reflected. Moreover, students entering (or not entering) the uine- 
lxne m response to a signal of over— or under-production tend to* behave 
congruently but without reliable perspective on how others are behaving 
Thus, the response to such a signal tends toward "all or none," resulting 
in an amplified, rather than the desired damped, response. 

Illustrative is the recent experience of the nation in the employment 
opportunities for elementary and secondary school teachers. The birth 
rate rose sharply from 19.5 per thousand in 1945 to 26.5 per thousand in 
1947 and remained at about this latter level until 1958; this harbinger 
of a need to accommodate about one million extra children per year in° 
each successive grade did not stimulate expansion of teacher production 
significantly until about 1952 or 1953 when the first cohort entered the 
school system and created a memorable perturbation involving elimination 
of kindergartens, overcrowding of classrooms, double sessions, tremendous 
overloads on teaching staff and so forth. 

In the heat of the fray, a peaking cf birth rates in 195S and im - 
mlsLakabie evidence of a downward trend by 1961 went almost unnoticed. 
In the prevailing crisis, few had the foresight to recognise the desira- 
bility of discontinuation of a policy of encouraging teaching careers 
and those sufficiently perceptive to recognize the new trend°and courageous 
enough to articulate the message were able to attract little attention! 
Accordingly, action was again late and the country now has an undeniable 
surplus of elementary and secondary school teachers. Thus, the nation 
has gone from famine to feast. However, if teacher production is now 
throttled too severly, the replacement requirements to meet: normal 
attrition and whatever expansion is required by population growth will 
not be met and we shall shortly be faced with famine again. 

This experience with regulating the supply of school teachers seems 
to me to share many aspects of our concerns in the area of graduate 
training and research manpower production. The nature of the problem 
passes a challenge to social planners, and particularly to their ability 
to establish the credibility of their predictions. Our society seems to 
frequently act too little and too late on the recommendations of planners. 
Social engineers are also challenged to devise methods for the regulation 
of supply in an orderly way, and for avoiding the seemingly inevitable 
brisk overreaction whenever the magnitude of an "error signal" describing 
the gap between reality and ideality of supply is announced. Alan Cartter, 
long viewed as a Casandra has recently emerged as a prophet. But college 
students may overreact to his forecasts with a consequent serious collapse 
in graduate enrollment. 



-4- 



Authoritarian countries are not of course confronted with severe 
problems of this sort, and in this country central regulation, by 
criteria and processes unspecified, is likely to be increasingly dis- 
cussed along with the price that such a process night extract. 

It seens to me that we have only begun to appreciate the range of 
new and unprecedented problems that will inevitably arise and confront 
the recently transformed enterprise of science. Since this effort is 
now to so large an extent the creature of public largesse and to so 
deep a degree dedicated to the solution of societal problems , many of 
the questions will have to be raised and answers formulated in the 
context of public policy. Dr. Bennett has taken "as far piece" down 
this road today. 



^cct 



ReprinitJ from 

11 February 1972, Volume 175, pp. 599 607 




Factors Contributing to Current 
Distress in the Academic Community 

Thomas J. Kennedy, Jr., John F. Sherman, R. W. Lamont-Havers 



Copyright© 1972 by the American Association for the Advancement of Science 



Factors Contributing to Current 
Distress in the Academic Community 

The growth of the NIH extramural program 
from 1960 to 1970 is analyzed. 

Thomas J. Kennedy, Jr., John F. Sherman, R. W. Lamont-Havers 



An analysis of the fiscal history of 
the National Institutes of Health (NIH) 
through the 1960's was undertaken in 
an attempt to explain the disproportion 
between the recent variations in NIH 
funds for biomedical research and the 
stress and perturbation currently expe- 
rienced throughout the academic com- 
munity. 

The institutes and research divisions 
of NIH (later abbreviated I/RD) obli- 
gated more funds for the support of 
research each year of the decade until 
fiscal year 1970, when obligations de- 
clined by 5 percent, and an increase in 
appropriations for the next fiscal year 
has permitted obligations in excess of 
those for 1970 by about 15 percent. 
The distress of the academic commu- 
nity, however, is due to quite tangible 



Dr. Kennedy is associate director for program 
planning and evaluation. Dr. Sherman is deputy 
director, and Dr. Lamont-Havers is associate 
director for extramural research and training. 
National Institutes of Health, Bethesda, Maryland 
20014. 



constraints and dislocations imposed by 
three principal factors: sudden decel- 
eration of program growth; inflation, 
sometimes exceptional in the biomedi- 
cal sphere; and marked variations in 
the funding of NIH components, each 
receiving separate appropriations from 
the Congress. 

During the decade, there have been 
a number of organizational changes, 
such as the creation of new institutes 
and divisions — National Institute of 
General Medical Sciences (NIGMS), 
Division of Research Resources (DRR), 
National Institute of Child Health and 
Human Development (NICHD), Na- 
tional Institute of Environmental Health 
Sciences (NIEHS), National Eye Insti- 
tute (NEI), and Division of Regional 
Medical Programs (DRMP) — both 
newly established and as a result of 
internal reorganization; the separation 
of components from NIH — DRMP and 
National Institute of Mental Health 
(NIMH); and the addition of new 



components — Bureau of Health Man- 
power Education (BHME) and Na- 
tional Library of Medicine (NLM). All 
fiscal data included in this report have 
been adjusted for these changes to en- 
sure consistency and compatibility. 



Budgetary History 

The NIH budget from fiscal year 
1960 through 1970 is presented in the 
aggregate, with several subsets that are 
of interest (Table 1). 

1) Many of the tabulated data are 
derived directly from budget activity 
schedules and are self-explanatory: reg- 
ular research grants, special program 
grants, general research support grants, 
research contracts, training grants, fel- 
lowships, and research facilities con- 
struction grants. 

2) The total of these obligations — 
extramural program (I/RD) — is a com- 
prehensive measure of current oper- 
ating support to grantee institutions 
and of long-range capital investment in 
their people (through training awards) 
and their space (through construction 
grants). 

3) Obligations for academic science 
include research, training, and facilities 
awards to academic institutions. 

4) A subset of these — awards to 
medical schools by the institutes and 
research divisions of the NIH — is avail- 
able only from fiscal year 1967 to date. 
Prior to that time, the series included 
awards to medical schools from NIH 
as well as the current components of 
the NIH. The formidable clerical task 
of stripping out the former data from 
the time series has not been completed. 
The combined NIH-NIMH data from 
fiscal 1960 to 1970 is still of consider- 



1200 



1000 



600 



400 



200 



Les£ND 

— Total NIH budget (institutes 4 research divisions) 
-Total NIH budget (l/RD's) in 1960 
Constant dollars (implicit total GNP 
deflator) 



300 



s 
200 2 



'60 '61 '62 '63 '64 '65 '66 '67 '68 '69 '70 

Fiscal year 
Fig. 1. Total NIH obligations: institutes and research divisions, 1960-70. 



able interest and hence is included in 
Table 1. 

In Table 2, major elements from 
Table 1 have been selected and normal- 
ized to reflect fiscal year 1960 as rep- 
resenting 100. The general patterns of 
growth are discernible, although the 
fairly large composites presented here 
tend to obscure the more precipitate 
changes in some of their elements vis- 
ible in Table 1. For example, the cate- 
gory of special program gTants began 
only in the decade covered and grew 
rapidly and steadily until recently, 
whereas health research facilities gTants 
had a meteoric decline. 

Figure 1, derived from Tables 1 and 



2, illustrates the patterns of growth. 
The aggregate growth in actual dollar 
level of most of the tabulated activities 
was steady and positive until about 
fiscal 1967. Since then, changes have 
been small. Most elements decreased 
in fiscal 1970. 



Toll of Inflation 

Fiscal obligations are the most read- 
ily available index of the principal mis- 
sion of the NIH — the support of the 
nation's biomedical research program. 
The basic program elements, such as 
people, institutions, and projects, are 



complex mixes, and it is difficult to 
find simple and meaningful character- 
istics that can be accurately measured. 
Obligations, however, reflect at least 
roughly the level of program activity 
supported and can be refined further 
to approximate the real state of affairs 
by taking into account several factors 
that modulate the extent to which total 
obligations are indicative. 

One refinement is to correct dollar 
growth for simple price inflation. The 
implicit price deflator for the total 
gross national product (GNP) is used 
throughout this article to convert "cur- 
rent" to "constant" dollars (see Table 
2 and Figs. 1-3). By this index, price 
inflation was modest until 1967, averag- 
ing about 3 percent per year. Annual 
increases thereafter have been between 
5 and 6 percent. 

The activities supported by the NIH, 
such as research and research training, 
include salaries of research and other 
personnel as their major (60 to 75 per- 
cent) cost element. There is evidence 
that salary scales have risen at rates 
considerably in excess of general price 
inflation. 

Each year, the Association of Amer- 
ican Medical Colleges solicits and pub- 
lishes data on the median salaries of 
"strict full-time" faculty (/). Between 
1964 and 1970 the annual compound 
rate of increase in salaries for all fac- 
ulty positions in eight clinical science 



Table 1. NIH obligations for various budget categories, fiscal years 1960-70 (in millions of dollars). 



Budget category 


1960 


1961 


1962 


1963 


1964 


1965 


1966 


1967 


1968 


1969 


1970 


Total budget (I/RD)* 


337 


451 


566 


662 


756 


837 


929 


1034 


1085 


1095 


1038 


Total extramural program (I/RD) 


283 


383 


499 


574 


656 


729 


806 


909 


947 


946 


881 


Total extramural research 


192 


265 


364 


414 


474 


519 


579 


684 


719 


728 


702 


Regular research grants 


163 


202 


266 


305 


351 


370 


402 


444 


456 


455 


437 


Special program grants t 


10 


27 


49 


41 


52 


56 


79 


104 


111 


116 


110 


General research support grants 




13 


18 


26 


30 


39 


39 


45 


54 


53 


50 


Research contracts 


20 


23 


31 


36 


41 


54 


58 


90 


97 


105 


105 


Training grants 


49 


70 


77 


86 


98 


106 


124 


134 


135 


142 


131 


Fellowships (and career awards) 


13 


18 


23 


30 


35 


40 


45 


49 


52 


55 


43 


Research facilities construction 


29 


30 


36 


50 


50 


65 


59 


42 


41 


22 





Total academic science (I/RD) 


211 


292 


372 


434 


492 


554 


610 


690 


710 


724 


647 


Research 


137 


189 


255 


292 


338 


372 


413 


483 


510 


529 


486 


Training and fellowships 


54 


77 


88 


103 


115 


127 


148 


163 


166 


176 


161 


Facilities construction 


20 


27 


29 


39 


39 


55 


49 


35 


35 


19 





Total medical school academic t 
























science (NIH and NIMH) § 


145 


209 


280 


302 


357 


397 


439 


4S2 


478 


508 


483 


Research 


92 


131 


195 


207 


241 


262 


287 


325 


314 


348 


338 


Training and fellowships 


40 


58 


65 


79 


94 


103 


121 


138 


142 


154 


145 


Facilities construction 


14 


21 


21 


16 


22 


32 


31 


18 


22 


6 





Total medical school academic 
























science (I/RD) 


NA|| 


NA 


NA 


NA 


NA 


NA 


NA 


436 


429 


452 


425 


Research 


NA 


NA 


NA 


NA 


NA 


NA 


NA 


308 


295 


327 


315 


Training and fellowships 


NA 


NA 


NA 


NA 


NA 


NA 


NA 


110 


112 


119 


110 


Facilities construction 


NA 


NA 


NA 


NA 


NA 


NA 


NA 


18 


22 


6 






• Total budget excludes foreign currency program (P.L. 4S0). t Special program grants includes P.L. 480 funding, 
for 1969-70. 5 Includes I/RD's, BHME, and NLM. || Figures not available. 



J. Includes schools of osteopathy 



Table 2. NIH obligations for various budget categories, fiscal years 1960-70, in current and 1960 constant dollars, normalized to 1960 = 100. The im- 
plicit price deflator for total gross national product (GNP) (1960 = 100) is utilized to convert current to constant dollars. Normalized constant dollars 
are shown in parentheses. 



Budget category 


1960 


1961 


1962 


1963 


1964 


1965 


1966 


1967 


1968 


1969 


1970 


Total budget (I/RD) 


100 


134 


168 


196 


224 


248 


276 


307 


322 


325 


308 




(100) 


(132) 


(164) 


(189) 


(213) 


(231) 


(250) 


(270) 


(272) 


(262) 


(236) 


Total extramural progam (I/RD) 


100 


135 


176 


203 


232 


258 


285 


321 


335 


334 


311 




(100) 


(134) 


(172) 


(195) 


(220) 


(240) 


(258) 


(282) 


(283) 


(270) 


(238) 


Total extramural research 


100 


138 


190 


216 


247 


270 


302 


356 


374 


379 


366 




(100) 


(136) 


(185) 


(208) 


(234) 


(252) 


(273) 


(313) 


(316) 


(306) 


(280) 


Training grants 


100 


143 


157 


176 


200 


216 


253 


273 


276 


290 


267 




(100) 


(141) 


(153) 


(169) 


(190) 


(202) 


(229) 


(241) 


(233) 


(235) 


(204) 


Fellowships (with career awards) 


100 


138 


177 


231 


269 


308 


346 


377 


400 


423 


369 




(100) 


(138) 


(169) 


(223) 


(254) 


(285) 


(315) 


(331) 


(338) 


(338) 


(285) 


Total academic science (I/RD) 


100 


138 


176 


206 


233 


263 


289 


327 


336 


343 


307 




(100) 


(136) 


(172) 


(198) 


(221) 


(245) 


(262) 


(287) 


(284) 


(277) 


(235) 


Total medical school academic 


100 


144 


193 


208 


246 


274 


303 


332 


330 


350 


333 


science (NIH and NIMH) 


(100) 


(142) 


(188) 


(201) 


(234) 


(255) 


(274) 


(292) 


(279) 


(283) 


(255) 



departments and in basic medical sci- 
ence departments was 6.0 percent. The 
annual rate of growth ranged from 4.4 
percent for chairmen of departments 
of psychiatry to 8.1 percent for asso- 
ciate professors of radiology. The over- 
all increase in faculty salary rates 
clearly exceeded that of simple price 
inflation, as demonstrated in Fig. 2. 
In September 1970 the staff of the 
National Cancer Institute (NCI) sur- 
veyed a sample of five important 
grantee institutions (and 12 major NCI 
contractors) to obtain data on changes 
in the cost of performing research dur- 
ing the period 1968-70. Grantee insti- 
tutions reported annual increases of 
6.8 percent for salaries, 7.3 percent for 
supplies, and 7.7 percent for equipment. 
Salaries accounted for 60 percent of 
their research costs. 

The rapid increase in faculty and 
research salaries could reflect inflation- 
ary pressure occasioned by the rapid 
infusion of federal research funds. 
Evidence that salary increases in cog- 
nate areas approximate what could be 
expected from simple price inflation 
(base salary X GNP deflator) would 
tend to support this hypothesis. 

Data collected by the Internal Rev- 
enue Service (IRS) (2), however, indi- 
cate that the professional income of 
physicians (either in solo or partnership 
practice) has escalated much more rap- 
idly than price inflation and a little 
more rapidly than the salaries of medi- 
cal school faculty ' (Fig. 2). These data 
suggest that the primary force pushing 
up academic faculty salaries has been 
competition for medical personnel in 
short supply rather than the increase in 
funds for research, reflecting the reality 
that medical school salaries must be 
competitive with income from the prac- 
tice of medicine if the schools are to 



recruit and retain clinical faculties. 

Although no comprehensive data are 
available on biomedical research salaries 
in industry, the NCI data mentioned 
above indicate comparability with the 
IRS data on physicians. The NCI con- 
tractors reported annual increases of 8 
percent for salaries and 4 percent for 
supplies and equipment. Salaries ac- 
counted for 70 percent of their research 
costs. Again it would appear that sal- 
aries in areas comparable to, but little 
affected by, NIH programs have 
mounted faster than costs in general, 
contributing to the stresses on the aca- 
demic community. 

Several other items that constitute 



substantially large cost elements in re- 
search budgets should be identified as 
taking a toll probably in excess of that 
reflected in simple price inflation. 

A measure of hospital cost increases 
may be gained from NIH experience in 
supporting clinical investigation. Special 
research grants for the support of gen- 
eral and categorical clinical research 
programs account for a significant por- 
tion of NIH research expenditures. An 
additional large amount of clinical in- 
vestigation is performed under regular 
project grants, where patients hospital- 
ized in "scatter beds" are studied. Over 
the last 5 years, the General Research 
Center program alone has supported an 



$ 50 



Partnerships . 
Proprietorships . 



Average 8 clinical departments — — 
40 Basic medical sciences 



E 



" Actual cost in current dollars 
-1964 cost adiusted for inflation 



30 



w 20 



10 



1964 



1965 



1966 



1967 

Year 



1968 



1969 



1970 



Fig. 2. Comparison of medical school faculty salaries ( 1) with net incomes of practicing 
physicians (2). Actual average figures are shown, with the exception of medical school 
faculty salaries for 1965 and net incomes of practicing physicians for 1969 and 1970 
(blank bars). For these years, approximate figures are based on the average annual 
growth rate of 6.0 for faculty salaries between 1964 and 1970, and of 8.0 and 7.2 for 
net income of physicians in proprietorships and partnerships, respectively, between 1964 
and 1968. Values for 1964 costs adjusted for inflation were obtained by applying the 
total GNP deflator to the 1964 base for each category. 



Table 3. Growth in direct costs of general clinical research centers, fiscal years 1965-70. 



Budget category 






Cost in dollars 






1965 


1966 


1967 


1968 


1969 


1970 


Personnel* 
Hospitalization* 
Other operating expenses 
Total direct costs* 


45 

41 

4 

90 


48 

46 

4 

98 


55 

50 

4 

110 


63 

56 

4 

122 


71 

63 

4 

138 


69 1 



* Cost per patient day. + Calculated on 80 centers in 1970 after 13 centers were closed. Comparable 
data on personnel costs not available. 



average of about 1000 beds (or a ca- 
pacity of about 365,000 patient-days 
of hospital experience). Table 3 illus- 
trates the increase in the direct costs of 
operating General Clinical Research 
Centers, which include the costs of fac- 
ulty, nurses, other patient-care person- 
nel, and hospitalization. Together these 
account for about 95 percent of the 
direct costs incurred by the centers. 
Figure 3 illustrates the national aver- 
age growth in daily service charges of 
all hospitals between 1960 and 1970 
(i). Clearly, the toll here far exceeds 
that of general inflation. 

The growing complexity of science 
has not only stimulated the develop- 
ment of increasingly complex instru- 
mentation, but has also been a conse- 
quence of such development. Indeed, 
the fact that new instruments make pos- 
sible the measurement of new properties 
of systems leads to the formulation of 
hypotheses that would not have been 
seriously advanced or even conceived 
in the absence of appropriate measur- 
ing devices for testing them. Progres- 
sive improvement in instrumentation 
has occurred, for example, in the field 
of microscopy, and has entailed con- 
siderable increases in cost. The digital 
computer, to mention another example, 
has come to play a large role in bio- 
medical research in the last decade. 
While costs for performing routine cal- 
culations have been reduced, greatly 



increased costs usually attend research 
in which the computer becomes an 
integral part of the instrumental en- 
semble, permitting execution of experi- 
mental procedures otherwise impossible. 
The period since World War II has 
been one of rapid expansion of the 
national as well as federal investment 
in research. This growth has brought 
large numbers of young investigators 
into the biomedical sciences. As these 
scientists mature and assume increasing 
responsibility, salary increases occa- 
sioned by promotions and advancement 
in faculty rank are superimposed on 
basic salary adjustments for cost of 
living or price inflation or both. This 
phenomenon has consumed a substan- 
tial part of the increments in NIH 
obligations. 



Toll of Indirect Costs 

In the domain of research, the indi- 
rect is as real and necessary a cost as 
the direct. Indirect costs have posed a 
difficult problem for many years. In 
the early days, when the level of NIH 
support was low, project research could 
usually be accommodated within a 
grantee institution's existing program 
activities, and the incremental overhead 
costs were small. As research assumed 
larger proportions, however, arbitrary 
federal limitations on reimbursement 



for indirect costs resulted in more sig- 
nificant burdens on performing insti- 
tutions. 

In lieu of reviewing the long and 
involved history of this issue, the fol- 
lowing summary may be made. With 
respect to research project grants, the 
NIH from 1955 to 1963 limited over- 
head to 1 5 percent of total direct costs. 
In 1963 the limit was fixed at 20 per- 
cent of allowable direct costs, which in 
practice worked out to about 16 per- 
cent of total direct costs. In 1966, in 
a major policy shift, the NIH began to 
pay full indirect costs and to require 
grantee institutions to share with the 
government in the total cost of each 
project. The basis for the rise in indi- 
rect costs is complex and not well un- 
derstood. Several factors have been 
implicated, but not clearly defined, nor 
has their relative importance been as- 
sessed. They include better identifica- 
tion of costs through more effective 
systems for grantee management, as 
well as inflation. 

Table 4 shows the direct, indirect, 
and total amounts awarded in research 
grants from 1965 to 1970. Total costs 
under grants have grown faster than 
direct costs, reflecting the rapid rise in 
indirect costs during the past 5 years. 
The rate of increase in total costs — a 
less accurate index of program activity 
than direct costs — overstates the rate 
of increase in program level. While the 
NIH favors payment of full indirect 
costs to grantee institutions, implemen- 
tation of this policy reduces the amount 
of research that can be purchased at 
any given level of funding. If this re- 
duction alone is added to the toll taken 
by inflation, the level of program ac- 
tivity for 1970 as reflected by direct 
costs is well below that for 1965. Thus, 
the decade of the 1960's saw an impres- 
sive rise followed by a sharp decline in 
the actual quantity of biomedical re- 
search supported by the NIH. 



Table 4. Growth in indirect costs of research grants of the ten NIH institutes, fiscal years 
1965-70, excluding NIH grants for general research support, general clinical centers, animal 
centers, and other special research resources administered by the Division of Research Re- 
sources. Total direct and indirect costs and total awards are shown in millions of dollars. 



Budget category J 


1965 


1966 


1967 


1968 


1969 


1970* 


Total direct costs 


332 


370 


410 


411 


399 


379 


Normalized to 1965 = 100 


100 


111 


123 


124 


120 


114 


Total indirect costs 


54 


63 


80 


92 


101 


104 


Normalized to 1965 = 100 


100 


117 


148 


170 


187 


193 


Total awards 


386 


434 


490 


503 


500 


483 


Normalized to 1965 = 100 


100 


112 


127 


130 


130 


125 


Indirect costs (percent 
of direct) 


16 


17 


20 


22 


25 


28 



1 1970 



estimates = funds available for obligation; excludes OMB reserves 



Pressure of Expanded 
Research Potential and Need 

Curtailment of available funds has 
coincided with an expanded potential 
for research, generated by the growth 
of grantee institutions, programs, and 
the pool of candidate investigators. The 
full measure of the pressure resulting 
from this potential is not necessarily 
reflected in the volume of applications 
for research grants, because express de- 
mand tends to track availability of 



funds and to shrink in the face of tight 
budgets. 

The number of trained scientists 
qualified for and expecting careers in 
biomedical research has grown remark- 
ably in the last decade. Data from the 
U.S. Office of Education (4) show that 
total graduate enrollment in the bio- 
sciences increased from 14,774 to 34,- 
861 between 1960-61 and 1970-71. 
The number of Ph.D. degrees conferred 
in these same disciplines increased from 
1193 to 3418 (5). Cumulatively, a sub- 
stantial number of doctoral-level scien- 
tists have been added to the research 
manpower pool over and above what 
could have been foreseen from 1960- 
level activity. Many of these have joined 
the nationwide competition for research 
support. 

A parallel growth has occurred in 
the number of physicians who have 
received research training experience 
during the course of their postdoctoral 
education and have since sought support 
for independent research. Enumeration 
of this group is difficult because it is 
not subject to a labeling procedure, as 
is the award of a doctorate. Between 
1963 and 1970 the NIH supported, 
through the mechanism of training 
grants and fellowships, an annual aver- 
age of approximately 4500 physicians. 
Almost four-fifths of those were fellows 
and full-time trainees. Past experience 
indicates that about half terminate 
training each year and, if opportunities 
arise, enter research rather than medi- 
cal practice. 

The number of institutions awarding 
advanced degrees has expanded. Since 
research is the method of graduate edu- 
cation in the sciences, these institutions 
have, by their very existence, expanded 
the competition for available research 
funds. In the 1960's, about 20 new 
medical schools were created in this 
country. Each has recognized that a 
modern science-based medical curricu- 
lum demands a vigorous, high-quality 
research program of at least modest 
proportions. 

During the 1960's a large number of 
problem areas potentially amenable to 
scientific approaches emerged, and 
many of them come within the purview 
of the NIH. Notable are population, 
mental retardation, human develop- 
ment, environmental hazards, child 
health, alcoholism, drug abuse, occu- 
pational health and safety, and the or- 
ganization and delivery of health serv- 
ices. Each of these fields is in compe- 
tition for health research funds. 



Role of Organizational 
and Managerial Factors 

Changes in the overall NIH budget 
and the impact of such changes on the 
aggregate level of supported research 
provide only a partial description of 
factors which NIH introduced and 
which bear directly on the academic 
biomedical research community. Super- 
imposed on the aggregate and average 
effects on research are specific events 
resulting from: interplay among the 
overall policies and procedures of the 
NIH, the individuality of each of its 
component institutes and the consequent 
inter-institute variability, and externally 
imposed rigidities and transients. The 
impact of these factors may be experi- 
enced with disproportionate severity by 
certain constituencies, and individuals 
or institutions may perceive incompre- 
hensible inequities. 

Yet the occurrence of unusual events 
from time to time can only be expected 
in view of the magnitude, diversity, and 
complexity of the effort conducted by 
the NIH. The research component of 
the agency operates with 12 sep- 
arate appropriations; processes about 
8000 competing research grant pro- 
posals each year, not to speak of appli- 
cations for about 7500 noncompeting 
research grants, about 3000 graduate 
training grants, and about 6000 fellow- 
ships and career awards; and utilizes 
50-odd study sections plus a roughly 
equivalent number of other initial re- 
view groups to evaluate proposals. The 
challenge of coordinating this vast proc- 
ess of fund allocation resides in the fact 
that the purposes for which support is 
sought are discrete yet highly inter- 
related. 



In the overall governance of the 
NIH, a style of operations which de- 
veloped over the last quarter-century 
forms a backdrop that should be kept 
in mind in examining specific causes of 
distress in the academic community. 

Research grant applications submit- 
ted to the NIH are processed through 
three screens: one for NIH-mission rel- 
evance by the NIH staff; one for scien- 
tific priority by study sections; and one 
for program priority — pertinence to the 
individual missions of the supporting 
institutes — by the national advisory 
councils. The study section review ac- 
cords a numerical score to each appli- 
cation deemed worthy of an investment 
of federal funds; the advisory council 
action modifies that assessment in a 
variety of ways by introducing what 
amounts to a weighting coefficient. Rec- 
ommendations emerge from the review 
process on the appropriate funding and 
duration of each project. The order of 
payment of approved applications is 
determined by the modified priority 
score. 

There are three cycles of review in 
each fiscal year. Institute directors with 
the advice of their national advisory 
councils must develop a strategy for 
obligating equitably the funds appropri- 
ated, with a view to supporting the most 
meritorious of the approved applica- 
tions whenever received during the 
fiscal year. 

More than two decades ago the NIH 
established a policy of funding out of 
current-year appropriations only the 
first year of a multiple-year award, and 
of according to continuation applica- 
tions under these awards the first claim 
on funds appropriated in subsequent 
years. These continuations were re- 



50 



_ 40 



— 30 



20 



Actual cost in current dollars 
1960 cost adiusted tor inflation 



253 



200 



I960 



1962 



1964 1966 

Calendar year 



Fig. 3. Growth of hospitalization costs, 1960-70; national average of daily service 
charges per patient (adult patient, two-bed room, short-term stay) (J). 



■'>■[■■■ (...! 1!.T 




Most meritorious Scientific ment/prog'am priority Leist meritorious 

[poor*Y »cw« Uivmi) hx pfoi'tm r«¥W«l 

Fig. 4. Probability that an approved com- 
peting proposal will be funded. 



garded as moral commitments. The 
discretionary funds available to an 
institute in any given year are those 
remaining after the moral commit- 
ments have been honored. 

As a matter of sound management, 
the NIH staff, through periods of com- 
mitted support, has negotiated awards 
upward or downward as warranted by 
progress in the conduct of a project 
and within limits established by the 
national advisory councils. Such nego- 
tiations are in no way incompatible 
with the poiicy of honoring moral 
commitments. 

The NIH has sought continuously, 
within limits imposed by the review 
process, to expand the number of in- 
stitutions engaged in biomedical re- 
search. As a consequence, an examina- 
tion of the distribution of NIH research 
support among institutions reveals a 
heavy concentration of funds in a rela- 
tively small number of institutions char- 
acterized by general excellence in 
science, together with a very broad dis- 
persion of relatively small amounts of 
funds to a large number of institutions. 
During periods of fiscal retrenchment, 
institutions with modest support are vul- 
nerable in many ways, and over the 
last few years a number of them have 
lost all NIH funding. 

Since 1937 a series of legislative and 
administrative actions have expanded 
the single National Institute of Health 
to include ten categorical institutes and 
several research divisions under the um- 



brella of a central administrative orga- 
nization known as the National Insti- 
tutes of Health. The cumulative effect 
has been to transform a small federal 
laboratory into an agency that accounts 
for more than half of all federal, and 
about a third of all national, support 
for biomedical research. Funds are ap- 
propriated by the Congress each year 
to the individual institutes, not to the 
umbrella organization; and transfer of 
appropriated funds from one institute 
to another is for all practical purposes 
impossible. Each of the institutes has a 
unique history and growth pattern of its 
own. 

A more detailed examination of the 
factors that account for the variability 
between institutes, and a more specific 
illustration of the consequences of these 
variations on individual investigators, 
grantee institutions, and fields of 
science, will help to illuminate the phe- 
nomena that are causing distress. 

Growth patterns in obligations by 
the individual institutes have varied 
significantly. In the past, almost three- 
fourths of the total funds available to 
an institute for research grants has been 
used to honor committed continuation 
projects; only the remainder has been 
available for competing applications. 
The funds awarded for noncompeting 
applications have tended to increase an- 
nually for almost every institute. Hence, 
for the several institutes whose total 
funds available for obligation declined, 
there was a disproportionately severe 
decrease in the support for competing 
projects (Table 5). 

The noncompeting funding require- 
ments are analagous to the obligations 
categorized as "uncontrollable." They 
are made up not only of moral commit- 
ments in the usual sense of the term, 
but also of grants in support of com- 
plexes called "centers" and "resources." 
The programs, emphasized in recent 
years, that these instruments support 
are broad, the objectives long-range, 
and the fiscal requirements large. Thus, 
resources and centers once initiated are 



Table 6. Percentage of research grant funds 
from the ten NIH institutes, by type of grant, 
fiscal years 1967-70. 



Table 5. Research grant awards from four institutes by type of grant, fiscal years 1967 and 1970. 







Millions of dollars 




Percent of total 


Institute 


Noncompeting funds 


Competing 


funds 


for competing 




1967 


1970 


1967 


1970 


1967 1970 


NICHD 


24.0 


26.9 


12.8 


13.2 


35 33 


NIAID 


29.0 


32.0 


17.5 


17.1 


38 35 


NCI 


48.5 


53.9 


22.1 


17.5 


31 25 


NHLI 


68.7 


66.4 


27.7 


20.0 


29 23 



Year 


New 


Re- 
newal 


Non- 
com- 
peting 


All 


1967 


23 


9 


23 


21'" 


1968 


23 


17 


24 


23 


1969 


19 


22 


26 


25 


1970 


16 


25 


28 


26 



more likely than regular projects to 
be sustained in subsequent competition 
for renewal. 

The cost of sustaining these large 
projects has risen each year. Since the 
total research grant funds available to 
the ten institutes and the Division of 
Research Resources have been relatively 
constant for the past several years, an 
increasing proportion of those funds 
would be expected to go for support of 
the large projects, not because of recent 
new starts but merely to sustain exist- 
ing programs. Table 6 shows the per- 
centage of each type of research grant 
funds. 

The net effect of these commitments 
to grants for resources and centers is 
to increase the uncontrollable expendi- 
tures and to decrease the discretionary 
funds for new and renewal awards. The 
level of available discretionary funds 
varies from institute to institute and 
from year to year; it reflects, in part, 
conventional moral commitments and, 
in part, the unique history of each 
institute's utilization of centers and re- 
sources to achieve its specific mission. 

Recently a smaller proportion of new 
grant funds has been awarded for pro- 
gram projects and centers, indicating a 
shift to the support of regular (and less 
costly) research projects. The rate at 
which this general trend is occurring 
varies from institute to institute. It is 
largely dependent on the extent to 
which the organization is involved in 
long-range commitments and the op- 
tions open to it to modify its ap- 
proaches in the light of the probable 
consequences of a policy change. 

As the program scope of the several 
institutes has evolved, some have tended 
to become increasingly the major source 
of support for specific fields and disci- 
plines. Thus the fortunes of those do- 
mains of science and the "patron" in- 
stitutes tend to rise or fall together. 

Other disciplines and fields derive 
support from several categorical insti- 
tutes. Thus, with differential growth in 
institutes, investigators of equivalent 



caliber may experience different success 
in obtaining support, reflective of the 
fortunes of the institute within whose 
program scope their work falls. Onco- 
genic virology, for example, will prob- 
ibly fare better than virology in general 
.'or the next few years as a result of 
the rapid growth in funds for cancer 
research. 

Certain grantee institutions, especial- 
ly free-standing research organizations 
with a heavy categorical focus, come 
to derive the major fraction of their 
total support from a single institute. 
Grantee institutions with small total 
support, based on isolated islands of 
scientific excellence, also tend to be 
funded by a single institute. Here again 
the fortunes of a grantee institution and 
an institute become coupled, and the 
special vulnerability of the grantee in- 
stitution in times of fiscal constraint is 
obvious. In the years 1967 to 1970, the 
total number of institutions of higher 
education receiving NIH research grants 
declined successively from 330 to 316, 
299, and 277. 

The fate of a particular competitive 
application is dependent not only on 
funds available to support it but also on 
the amount of competition it must face 
within the institute to which it is as- 
signed. At any time, the total flow and 
distribution of new, competing re- 
newals and noncompeting continuation 
grants differ for each institute and may 
depart significantly from the aggregate 
pattern for the NIH as a whole. 

Each of the approximately 50 study 
sections has a discrete pattern of re- 
sponse to the new and renewal applica- 
tions it reviews. Since the study sections 
tend to be organized along disciplinary 
lines, and the institutes along lines of 
categories of disease, each study section 
reviews applications assigned to many 
institutes (though most are related to a 
few institutes). The result is that the 
approval rates which the initial review 
groups (IRG's) accord a group of ap- 
plications vary by institute and over 
time. 

Approval rates of renewal applica- 
tions have been consistently greater than 
have those of new applications. This is 
to be expected, since each renewal ap- 
plication represents a project that once 
competed successfully as a new applica- 
tion. The winnowing process has al- 
ready selected the applicant as a more 
Tomising investigator than his unsuc- 
:essful former competitors. In the con- 
text of this discussion, the fate of an 
application, viewed statistically, is re- 



Table 7. Number of competing and noncom- 
peting grants of the ten NIH institutes, fiscal 
years 1962-70. 



Year 



Com- 
peting 



Noncom- 
peting 



All 
projects 



1962 


4,573 


7,509 


12,082 


1963 


4,387 


8,144 


12,531 


1964 


3,966 


8,475 


12,441 


1965 


3,766 


8,457 


12,223 


1966 


3,494 


8,476 


11,970 


1967 


3,879 


7,992 


11,871 


1968 


3,023 


8,092 


11,115 


1969 


3,324 


7,596 


10,920 


1970 


2,605 


7,226 


9,831 



lated to whether it is a new or renewal 
proposal. 

The variable pattern of IRG behavior 
is reflected not only in approval rates 
but in the distribution of priority scores 
for approved applications. Moreover, 
within a single IRG, dynamic trends are 
occasionally discernible as the member- 
ship changes, as the field matures or 
goes into eclipse, or as other forces 
supervene. The net result is further in- 
ter-institute variation in the scientific- 
merit priority scores. 

Each institute has a distinct mission 
or missions, usually categorical, as in 
cancer, heart, or arthritis. Therefore, its 
program director, with the assistance of 
the members of its national advisory 
council, must develop a plan for attain- 
ing the central goals of the organiza- 
tion. This strategy results in emphasis 
on certain fields or disciplines or areas 
of science. Thus, proposals of roughly 
equivalent scientific merit (understood 
in the light of the previous discussion of 
variation in IRG behavior) are ad- 
judged as more likely to advance the 
missions of an institute if they are in 
certain fields. Conversely, applications 
of equivalent merit from a specific field 
are likely to be assigned different pro- 
gram priorities by different institutes. 
Thus, in each cycle of review, the num- 
ber of competing applications received 



Table 8. Funding rates for new and renewal 
research grant proposals, National Institute of 
General Medical Science (NIGMS) and all 
NIH institutes, fiscal years 1967-70 (percent- 
age of IRG-approved proposals funded). 





New 


pro- 


Renewal 


pro- 


Fiscal 


posals 


(%) 


posals (%) 


year 












NIGMS 


NIH 


NIGMS 


NIH 


1967 


53 


74 


67 


80 


1968 


29 


57 


46 


73 


1969 


49 


63 


68 


70 


1970 


13 


42 


32 


60 



by a given institute varies absolutely 
and in relation to that of other insti- 
tutes. Moreover, the prospects of award 
are modulated by complex influences 
exerted by study sections, national ad- 
visory councils, and institute program 
objectives. 



External Limitations 

From time to time unexpected inter- 
ruptions, limitations, and contingencies 
arise to create managerial problems. 

Occasionally an item in a budget 
is earmarked for a narrow, highly spe- 
cific objective. This dedication of funds 
may occur within the Executive Branch 
during the development of the Presi- 
dent's budget or may be imposed by the 
Congress. The effect is an expansion of 
uncontrollable expenditures and a re- 
duction of funds for flexible and discre- 
tionary use. By its very nature, limita- 
tion of this sort can have an impact 
that may well seem capricious. 

The NIH grew at a rather steady 
rate for many years, and its procedures 
and processes were based on and geared 
to such a growth pattern. Patterns of 
experience, expressed in operating sta- 
tistics, for projecting future manage- 
ment of the agency's responsibilities 
necessarily reflected this history. The 
relatively sudden cessation of growth 
which began in the late 1960's required 
adjustments to a new set of expecta- 
tions, reexamination of the total set of 
policies that had developed since about 
1950, and decisions on long- and short- 
range modifications of policies, proce- 
dures, and practices. Action pursuant 
to such decisions tended to be applied 
in situations already scheduled for ac- 
tion according to existing timetables — 
for instance, competing grants — rather 
than across the board, in order to avoid 
destabilizing the entire biomedical re- 
search community. Thus, as noted 
above, a shift away from emphasis on 
long-term grants was first manifest 
from action on new and renewal grant 
applications, but the full extent and im- 
pact of this trend will not be apparent 
until all grants of this type reach the 
end of their project period and reenter 
national competition. Since each insti- 
tute has different requirements and thus 
different proportions of such grants, 
and somewhat different expectations, 
the pace and extent of change have 
varied. 

From fiscal year 1962 through 1968, 
the research grant funds awarded by the 



Table 9. Factors determining whether a scientifically meritorious competing proposal will or will 
not be funded by the NIH. 

Extrinsic to the NIH 
Proposal relates to program with a large/small public constituency. 

Related to program having/not having presidential, congressional, or departmental priority. 
Line item/no line item in budget for program. 
Submitted during period of rapid growth/stability or decline in funding institute. 

Intrinsic to the NIH 
Processed by a study section disposed to give high/low priorities. 
Area of high 'low institute program priority. 
Competing renewal application/ new application. 
Submitted to a funding institute with a small/large number of long-term commitments (centers, 

program projects) and relatively great/little flexibility. 
Funding decision coincident with time when many/few options are open within annual funding 

strategy of patron institute. 
Related to a field or discipline widely regarded as undersupported/oversupported in scientific 

or program terms. 
Proposal relatively original/unoriginal; comparable ones are not/are in competition; little/much 

related work in progress. 



ten research institutes (or their prede- 
cessor units) increased steadily from 
$332 million to $503 million. In 1969 
and 1970 the total amount decreased 
somewhat, reaching $483 million. Table 
5 indicates the trends in the number 
of competing (new and renewal) and 
noncompeting projects supported by 
the ten institutes. 

Competing awards declined sharply 
between 1967 and 1970. The year 1969, 
however, was exceptional, probably be- 
cause the NIH, faced with what was 
first thought to be a transient curtail- 
ment of funds, decided to modify its 
policy of moral commitments and to 
negotiate all noncompeting awards 
downward to an average extent of 10 
percent beyond normal negotiations re- 
quired by sound management. This ac- 
tion was intended to maintain as many 



investigators as possible through a pe- 
riod of crisis. Moreover, the NIH could 
not have reasonably complied with the 
ceiling on expenditures imposed by the 
Congress through the Revenue and Ex- 
penditure Control Act of 1968 (P.L. 
90-364) without limiting the obligations 
for noncompeting grants. 

In the following year, the attenua- 
tion of growth seemed likely to con- 
tinue. Hence, the NIH decided to cur- 
tail arbitrary across-the-board negotia- 
tions and to resume insofar as possible 
its long-standing policy of supporting 
projects with the highest program pri- 
ority minimally but adequately, relegat- 
ing to a secondary role the objective of 
maintaining stability throughout the bio- 
medical research community. 

The fiscal stringency experienced 
since 1969 has exposed previously 



Table 10. Summary of NIH research obligations by program, fiscal years 1970-72 (estimated). 
Budget authority in millions. Excludes P.L. 480 programs and NIMH portion of genera] 
research support grants. 



Institutes and 
research divisions 




1970 

(comparable) 


1971 

(estimated) 


1972 

President's 

budget 

(final) 


Total budget (I/RD) 
Allergy 
Arthritis 




$1,012.5* 
94.1 
128.4 


$1,166.3* 
98.1 
134.4 


$1,291.8 
99.3 
135.4 


Biologies standards 
Cancer 




7.9 
179.0 


8.7 
230.5 


9.0 
234.3 


Child health 




75.4 - 


93.7 


103.2 


Dental 




28.3 


34.7 


38.8 


Eye 




24.2 


30.4 


32.6 


Environmental health 




17.2 


20.0 


25.3 


Fogarty International 


Center 


3.2 


3.7 


3.3 


General medical sciences 


142.9 


154.5 


150.4 


Heart 




156.7 


191.6 


195.5 


Neurology 
Research resources 




92.7 
62.7 


99.5 
66.4 


96.5 
68.1 


Cancer conquest program 






100.0 



• Reflects comparative transfer of $23 million from the institutes to BHME for research 

grants. 



masked consequences of the early NIH 
policy decision to support research 
through the funding of individual proj- 
ect proposals. In essence, a project sys- 
tem embodies the principle of cost - 
reimbursement: the amount awarded 
reflects the best peer judgment of the^i 
reasonable costs required to complete 
work of the scope proposed. Thus it 
makes little sense to provide less than 
full support, notwithstanding the im- 
pulse to spread available funds among 
all approved proposals during times of 
fiscal stringency. Recognizing this, the 
NIH proposes to all but eliminate 
arbitrary negotiations of moral com- 
mitments by fiscal year 1972. 

The experience of 1969 illuminates 
the fact that two NIH policies, both 
widely regarded as highly desirable — 
to honor moral commitments and to 
fund approved applications by rank 
order of program priority — while quite 
compatible when budgets are rising, 
corns into sharp conflict under con- 
tracting fiscal circumstances. It also 
reveals that honoring moral commit- 
ments increases the uncontrollables 
and thus restricts during periods of 
fiscal stringency the funding of new or 
renewal projects of equivalent scien- 
tific but higher program priority. 

Between 1962 and 1968 other fac- 
tors that contributed to the reduction 
in the number of projects were the 
trend toward larger projects in which 
several small ones were consolidated, 
and the more rapid gTowth in the unit 
cost of research than in funds avail- 
able. This situation was brought about 
because of inflation, technological 
complexity, investigator salaries, and 
indirect costs. 

The net result of the operation of 
all the factors discussed is reflected in 
the number of approved projects that 
a given institute funds. Recent trends 
for one of the institutes, compared here 
with the total experience of the NIH, 
reveal the pattern illustrated in Table 
8. Comparable data for all the insti- 
tutes show wide variation, not only in 
comparison with other institutes but 
from year to year. Even the cumulative 
effect for the entire NIH shows striking 
changes over a period of only 3 
years. 

In the light of this analysis, it is pos- 
sible to outline the circumstances under 
which an application of high intrinsic 
scientific merit would have the greates 
or least probability of funding (Table - 
9). 

The abstract graphic representation 



in Fig. 4 indicates that at any given 
state of NIH affluence, an application 
of given priority will encounter a range 
of probabilities of funding depending 
on a number of prevailing circum- 
stances. Most applications processed 
through the system encounter a mix- 
ture of factors, some enhancing, some 
reducing the probability of success. 
Rarely are the circumstances all un- 
favorable. Individuals, grantee institu- 
tions, or the research community in 
general may infer from the improbable 
case that the system is basically given 
to capricious or idiosyncratic behavior, 
an impression reinforced by the tend- 
ency for memories of such events to 
accumulate and persist. 

Neither the available data nor the 
more subjective analysis of Fig. 4 
conveys adequately the impression, 
strengthened by recent events, that in- 
herent conflicts between competing and 
equally meritorious goals in a federal 
support program can become crucial 
when funds are curtailed. Support of 
innovative ideas, which tend to be 
risky, competes with support of lines 
of proven productivity; and mission 
relevance, with scientific merit. 



Discussion and Conclusions 

The data presented in this analysis 
identify the major bases for the con- 
cerns that have been aroused in the 
biomedical research community. While 
the total budget for research, measured 
in current dollars, remained about level 
from fiscal year 1967 to 1970, the 
amount of research supportable with 
these dollars undoubtedly declined con- 
siderably. Particularly was this true of 
the salaries of the professional person- 
nel who carried out the investigations. 
For example, the rate of increase of 
salaries of medical school faculty has 
exceeded the toll attributable to infla- 
tion, and the NCI study indicates that 
this may also be true of the salaries of 
investigators in industry. As a conse- 
quence, the actual quantitative level of 
research declined even more rapidly 
than the direct costs measured in con- 
stant dollars (Table 4). 

The leveling off of biomedical re- 
search funding coincided with an ex- 
pansion of potential for research per- 
formance, attributable to an increase 



in the number of scientists and of in- 
stitutions granting the doctoral degree, 
as well as to an expansion of the scope 
of problems viewed as appropriate for 
support from public funds. 

The sheer magnitude and complexity 
of the NIH budget and the logistics of 
managing it have occasioned unex- 
pected year-to-year and institute-to-in- 
stitute vagaries, the impact of which 
becomes most apparent when oper- 
ating in conjunction with budget re- 
strictions. 

The research community has experi- 
enced considerable difficulty and major 
disruptions in coping with these prob- 
lems. Moreover, the decreases, both 
substantial in magnitude and relatively 
sudden, have occurred as other costs 
of operating institutions that are per- 
forming research have risen. The insti- 
tutions are additionally subject to the 
stresses of a greatly increased demand 
for their special capabilities and re- 
sources. 



Epilogue 

In January 1971 the appropriation 
act for fiscal year 1971 was signed into 
law, and in February the President's 
budget for fiscal 1972 was published. 
The latter document indicated that the 
Executive Branch plans to obligate vir- 
tually all the funds appropriated for 
fiscal 1971. 

In Table 10 fiscal 1970 obligations 
are compared with estimates for 1971 
and requests for 1972. The data are in- 
ternally compatible, but for reasons of 
accounting use a different format, em- 
brace a somewhat different universe, 
and yield a different aggregate 1970 
obligation figure than appears else- 
where in this text. 

The budget of each of the institutes 
has increased. In the aggregate, the 
total estimated obligations for fiscal 
year 1971, measured in 1960 constant 
dollars, will exceed slightly the fiscal 
1969 level, but not the levels of 1967 
and 1968. If the Congress appropriates 
and the President authorizes obligation 
of the total budget requested for fiscal 
1972, obligations for that year will 
match or slightly exceed the peak 
achieved in the 1967-68 period. 

The projected aggregate increase is 
not uniformly distributed among the 



institutes. The NCI, NICHD, NEI, 
NIEHS, National Heart and Lung In- 
stitute, and National Institute of Den- 
tal Research would gain substantially, 
in both relative and absolute terms. 
This reflects increasing federal commit- 
ment to targeted research programs in 
cancer, atherosclerosis, population and 
family planning, dental caries, eye 
diseases, environmental health, and 
sickle cell anemia. Substantial fractions 
of the increases will be used, under con- 
tracts, to conduct centrally planned and 
managed research and development en- 
deavors. 

By contrast, the projected increases 
for the other institutes — the NIGMS, 
National Institute of Allergy and In- 
fectious Diseases, National Institute of 
Arthritis and Metabolic Diseases, and 
National Institute of Neurological Di- 
seases and Stroke — are uneven and 
modest. In constant dollars, the in- 
crease over the 2-year period will 
probably not compensate for inflation- 
ary reductions in program level. 

The fiscal 1971 and 1972 budgets 
indicate that a reversal of the trends 
which characterized the latter part of 
the past decade has begun. Changes 
appear to be specific, not general. All 
of the variables of recent years must 
be considered in meeting the detailed 
impact of the budget increases antici- 
pated for fiscal 1972. 

References and Notes 

1. Average salaries of medical school faculty 
were calculated from data reported in "Data- 
grams," Assoc, of Amer. Med. Coll. 10, No. 
10 (Apr. 1969); ibid. 11, No. 6 (Dec. 1969). 

2. Net incomes of practicing physicians were 
calculated from data reported in the following 
publications: Internal Revenue Service: Statis- 
tics of Income — 1964, Business Income Tax 
Returns (Government Printing Office, Washing- 
ton, D.C., 1967); ibid, for 1965 (Government 
Printing Office, 1968); ibid, for 1966 (Govern- 
ment Printing Office, 1969); ibid, for 1967 
(Government Printing Office, 1970); Prelimi- 
nary Statistics of Income — 1968, Business In- 
come Tax Returns (Government Printing Office, 
Washington, D.C., 1970). These data were 
based on preaudited, stratified samples of in- 
dividual income tax returns. Form 1040 (pro- 
prietorships), and partnership returns of in- 
come, Form 1065 (partnerships). 

3. Data were abstracted from Daily Service 
Charges in Hospitals, 1960 through 1970 
(American Hospital Association, 1961 through 
1970). 

4. Students Enrolled for Advanced Degrees: In- 
stitutional Data, Fall 1969, Office of Education 
54019-69 Part B (Government Printing Office, 
Washington, D.C., 1970). 

5. Doctorate Recipients from United States Uni- 
versities, 1958-1966 (National Academy of 
Sciences-National Research Council, Washing- 
ton, D.C., 1967); Doctorate Recipients from 
United Stales Universities: Summary Report 
1970 (National Academy of Sciences-National 
Research Council, Washington, D.C., 1971). 



BASIS FOR DETERMINING 
RESOURCE ALLOCATION FOR BIOMEDICAL RESEARCH* 

Thomas J. Kennedy, Jr., M.D.** 

Society's expectation from research in the biomedical sciences is 
the solution or amelioration of problems that threaten life and health. 
While modern medical science has made tremendous progress, tremendous 
problems remain— problems that tragically limit personal fulfillment and 
achievement. Tne direct cost of disease, about $?6 billiofTpST year, 
represents only the most visible expense. Indirect costs, judged by 
measures such as lost productivity, are enormous and even then fail 
completely to reflecL the grave psychological and social burden of illness 
to individuals and their families. 

In the last decade or two, public attention has focused on serious 
problems concerning the quality, accessibility and costs of health care, 
the financing mechanisms, and the availability of health manpower and 
facilities. But celivery capability can be no better than the current 
state of knowledge. The latter is completely determined, and limited, by 
the effectiveness of research. Thus it is important to examine the 
determinants of resource allocation for the medical research effort. 

Biomed i caL-Rese arch a nd Social Goals 
Direction of research toward certain objectives does not automatically 
result in their attainment. Research is a complex activity that must be 



* Delivered at the ".'ill Orientation for HE 1 ,-,' Mana^c-ment Interns, 

2/29/72, at the National Institute: of Health, 3ethe?da, Md. 

**Associace Director for Program Planning and Evaluation, SIH. 



viewed in terms of the individuals who perform it, the institutional 
settings in which they work, the resources available for the task, and 
the current state of knowledge in the specific research area. 

Discoveries come in a variety of forms, from generalizable conclusions 
that illuminate large segments of biology and medicine to specific findings 
of narrow applicability. Interplay between these enables some creative 
scientists to discern universals in the mass of detailed data, and others 
to discover the applicability of broad principles to a specific problem 
area. Thus inductive and deductive processes lead to new and creative 
syntheses, theories and applications. 

Realization of society's expectations depends on the extent to 
which individual L'cbcdiui vvuikeib, ins Li LuLioiiui research performers, 
and resource allocation processes can be aligned with social goals. The 
last quarter century has seen the forging of machinery capable of converting 
society's expectations of biomedical research to reality. This has been 
achieved principally through steadily rising Federal support, the creation 
of a national network of scientific capabilities and institutional 
commitments, and the development of the National Institutes of Health as 
the lead agency. 

National expenditures for health research have increased from a token 
level of $87 million in 1947 to approximately $3 billion in 1971 — a growth 
rate of 16 percent a year. This growth has been paced by rising Federal 
investment in hea]th research, which grew at the rate of 20 percent a 
year, mounting frcm $27 million in 1947 to $1.9 billion in 1971. Both 



the national and the Federal research investments seek solutions to 
urgent health problems, such as cancer, heart disease, mental illness, 
congenital abnormalities, family planning, child health, aging, and 
environmental pollution. Scientists in government, industry and the 
nonprofit sector — primarily academic institutions and medical schools — 
collaborate in the pursuit of health research objectives. 

Public interest in health research has been dominated by a pre- 
occupation with specific diseases that are highly visible, associated 
with high mortality rates, and often characterized by prolonged suffering 
or disability. Reinforced by such dramatic developments as the prevention 
of polio, medical research has gained strong public support since Worl.H 
war II. The categorical research institutes of SIH manifest governmental 
concern with discovering the causes of disease and developing techniques 
for their prevention and control. 

The Issue 
Against this historical background, it is clear that the emergence 
of the Federal Government as the dominant source of support for biomedical 
research has imposed key responsibility for program balance upon Federal 
legislators and executives. These officials must constantly seek to 
optimize limited resources by achieving a balance among competing 
approaches to the solution of research problems. In addition, they must 
continuously examine whether the national or. Federal investments should 
grow, shrink, or remain stable over the periods for which long-range 
forecasts are attempted. Thus the specific issue posed here is, At what 



level should biomedical research be supported over the next five years' 
To address this issue , I propose today — 

• to outline sone of the analyses and arguments that have 
been employed to assist in a determination of appropriate 
levels cf support for research and development; 

• to describe considerations that have led tc recommendations 
for future levels of support by the NIH; and 

• to examine the processes through which such recommendations 
are transformed into allocations for expenditure. 

Theoretical Considerations 



For a little more than a decade, there has been a fairly lively 
literature cognate to some aspects of the issue under discussion. Perhaps 
the treatment of the subject had its finest hours during the period 
1962-1965 when a series of stimulating articles appeared in Minerva , 
centering on the problem of scientific choice, and when the National Academy 
of Sciences commissioned a series of scholarly essays in response to questions 
posed by the Committee on Science and Astronautics of the U.S. House of 
Representatives . 

This body of thought was responsive to a series of events that took 
place from 1940-1960. These included: the professionalization of research; 
its institutionalization on an unprecedented scale; the emergence of a 
broad consensus that the maintenance of research on the prevailing scale 
required substantial and continuing public support; and the recognition 
that research was approaching levels of public expenditure that pieced it 



in competition with other societal goals. 

The discussion focused on a number of facets of the problem of 
scientific choice and led to speculation about the value- of science. 
Attention was devoted to such problems as choice between fields of science, 
between "big" and "little" science, and between elements of the complex 
sequence basic science /technological development/testing. 

In the efforts of the NIH to rationalize its claims on the national 
budget, the specification cf social goals and subgoals, the criteria for 
ordering these, the nature and character of the value atta'clned - to them, 
and the metric of that value have been -extraordinarily difficult to 
state explicitly, and therefore to use in advocacy or decision-making. 

Iu contemporary literature, social goals appear to be valued almost 
exclusively in economic terms. The NIH, however, holds strongly to the 
position that the general goal of its research programs — health — is to be 
prized above all others in human terms. The NIH staff was gratified to 
note that the economic benefits of developing effective vaccination 
procedures against poliomyelitis considerably exceeded the costs. 
Nevertheless, those who are old enough to remember how the announcement 
of the first polio case of the season struck terror in the breasts of parents 
will little doubt that most Americans sought more than economic value in 
their generous support of polio research. 

But whether the social goals are humanistically or economically 
based, a very distinct impression is inescapable: the predominant motivation 
behind public support in the United States is utilitarian. Scientists 
are expected to attain goals that are regarded as useful to the society. 



An outstanding feature of this growing body of literature is the 
absence of any intellectually convincing algorithm for arriving at an 
optimal level of expenditure. Ever, when the context is utilitarian, a 
transformation of a social objective into dollar levels of support for 
research has remained intractable, and almost all attempts have been 
within narrow economic value systems. 

One theme that, undergirds all economic analysis is that the more 
basic the research problem, the more severely the private sector under- 
allocates research support, through imperfections in the market; mechanism. 
Hence, as the argument runs, the public -sector must assume the major 
responsibility for support of the most basic research, with the private 
sector not really expected to invest unless the state of knowledge is 
near the point of product realization. 

The level of research investment defined in theory as optimal is 
that at which the marginal social benefit equals that of alternative uses 
of the dollar. Marginal social benefit — akin to a benefit/cost ratio — 
is the benefit to be had from the last dollar invested in the activity. 
Presumably the benefit from an additional dollar invested will change 
and at some point begin to fall. As soon as the marginal benefit fails 
below that of alternative projects, the allocation processes will switch 
to a new project; and this will continue until all marginal benefits are 
equal — that is, until the benefit from the last dollar is equal for all 
possible alternative projects. 

The definition of optimality in economic terms fails, of course, to 
recognize that in the case of research on human disease, there is a 



7' 

transcendent urgency to the pursuit. It could even be argued that 

investment in biomedical research should continue until the return 

actually becomes negative, rather than stop when the ratio falls below 

that of an alternative use of the funds. 

Benefit/cost analysis assumes that a unique and unambigous monetary 

A 

value can be placed on each social benefit achieved — an assumption 
patently untenable. It also assumes that accurate estimates of the cost 
necessary to achieve a given social benefit — say, the conquest of cancer — 
are possible, an equally untenable assumption in a very large'domain of 
medical science. — 

Another line of economic argument relates to estimates of "willingness 
to pay." If every person's utility for health could somehow be assessed, 
and if his willingness to invest in his own future health could be 
approximated, all these preferences could be aggregated to yield a better 
estimate of society's wants than is reflected in Congressional appropriations , 

Yet another line of economic analysis is based on the strong hunch 
held by most economists that research contributes positively and signifi- 
cantly to economic development and productivity. Presumably, the health 
benefits created by research affect the labor force and thus benefit the 
economy as a whole. The applicability of the argument, however, to 
predict optimal levels of research investment is tenuous. The data are 
soft, and the relationship is quantitatively uncertain. 

Another form that this general thesis has taken is that research 
should be viewed as an overhead cost commanding some arbitrarily chosen 
fraction of the cost of the total activity. Thus, a percentage of the 



8 

value of the total output of an industry could be viewed as an appro- 
priate research investment. With improved insight, refinement of the 
size of investment toward "optimality" might be possibles Accordingly, 
it has been suggested that some historically precedented fraction of 
the Nation's health expenditures be asserted as appropriate "overhead" 
or "skim" on future health expenditures and be diverted to biomedical 
research . 

The principal difficulty with this approach is that it involves 
highly arbitrary judgment. Nonetheless, some rules of thumb that attempt 
to peg research investments to a cognate measurable index — total medical 
expenditures, gross national product, etc. — may be useful in determining 
the rough upper and lower bounds of the reasonableness Df proposed levels 
of investment. 

Other rules of thumb would estimate the appropriate level of research 
from the cost of supporting some fraction of all the available research 
manpower. It has been advocated, for example, that in respect to the. 
balance between "big" and "little" science, virtually all competent U.S. 
scientists engaged in "little science" should receive support. 

Practical Considerations 



All things considered, the NIH has concluded that no theoretical 
basis for examining the question at issue is operationally adequate. The 
practical consequence of this judgment is that short- and long-range 
budget recommendations must be developed pragmatically. The NIK budget 
recommendations are developed each year in the light cf three major 



considerations: the objectives of the program; the extant and emerging 
opportunities; and the relative and absolute limitations on action. I 
should like to discuss these considerations briefly. 

Objectives 

The broad objectives of each appropriation — the NIH is the collective 
of 16 separate appropriations, 12 for research — are spelled out clearly in 
the documents that created each component of the organization. The 
National Heart Institute, for example, was created by the Congress in 1948. 
For a variety of reasons, its name was changed to the National Heart and 
Lung Institute, encompassing pulmonary disease within its purview. Major 
subobjectives, usually diseases within each general category, are defined 
by program officials and are reasonably self-evident. 

In reality, each subobjective is a rather large domain and can again 
be subdivided, down to fields sufficiently circumscribed to reflect the 
efforts and interests of an identifiabl group of investigators, to serve 
as a suitable universe for state-of-the-art assessments, and to be the 
context for "crystal-balling" with some credibility. 

It cannot be over-emphasized that research is a risky enterprise; 
investments carry no guarantee of success. Cancer, for example, has not 
been conquered despite 34 years of expanding investments in cancer research, 
True, much progress has-been made; cancers of certain specific types are 
now preventable cr curable. But the next "breakthrough" is unpredictable. 
The crystal ball is cloudy on the question of when? by what individual? 
through what avenue of investigation? Thus, the NIH takes the view that 



10 

the Nation must commit itself to a steady biomedical research effort 
across a broad front of science. 

Moreover, the complex system for biomedical research created over 
the last quarter century must be sustained. This system involves a 
network of institutions in the public and private sector. Colleges 
and universities dominate the latter and have become the major performers 
of federally sponsored biomedical research. The system includes a pool 
of scientific workers who are connected through a complex skein of relation- 
ships. It also includes physical facilities, prone to obsolescence, that 
must be renovated periodically or replaced. 

The NIK, in the light of its statutory responsibilities, must be 
dedicated i;o the preservation of this network of kindred individuals and 
institutions. The research project grant has been an ideal instrument 
to ensure mission relevance and, operated in a peer-judgment review context, 
to control the quality of the effort. 

Achievement of Federal research objectives will depend, in part, on 
the flow of funds into the system to permit a reasonably stable level of 
activity. Sharp transient funding increases can be managed unless they are 
very large-. Decreases, on the other hand, can lead to rapid and permanent 
loss of key personnel, with sudden collapse of the system. 

Stabilization of the system for biomedical research depends on the 
following factors: 

e a long-term commitment by the Federal agency to a level of funding 
for nationally competitive project-grant research that will not be 
subject to capricious and unexpected fluctuations, particularly in 



11 

a downward direction; 
c the availability of research-related contingency funds to be 
used by academic institutions to handle the transitional as 
well as capricious local perturbations in the career patterns 
of individual scholars; 

• a carefully planned program for research manpower development 
to meet losses and growth requirements; and 

• a commitment to maintain and, if appropriate, to expand the 
"plant capacity" — the facilities necessary to perf oTm'lfealth 
research. — v 

So long as the total system or network of research activity is stabilized, 
the problem of most individual institutions will probably be manageable. 

The optimal balance between project grant support and institutional 
support is an important consideration. Obviously, too much institutional 
support, tending to the establishment of sinecures for research-oriented 
faculty, would be undesirable from the point of view of the individual, 
the institution, and the supporting agency. Both stimulation and quality 
control would tend to decline. Too little institutional support, on the 
other hand_, would place the research-oriented faculty members and their 
institutions in a very hazardous position, vulnerable to sudden decrements 
in support due to unexpected fluctuations. Prevalence of this situation 
would be incompatible with a viable national research effort. 

The central concern in a discussion of stability turns on the 
confidence of the research community in the depth, durability and 
predictability of the Federal commitment and in the resolve of the Government 



12 
to sustain this commitment in the face of unexpected vicissitudes. 

Opportunities 

With respect to research opportunities as a factor in budget formula- 
tion, it may be posited that the only patently rational basis for justifying 
research investments is the identification of good ideas and good people — 
people who have had good ideas in the past and are likely to have them in 
the future. The central problem is tc identify these ideas and these 
people and to place them in proper perspective. 

The search for emerging ideas is continuously under~~way~at the NIK. 
The most fruitful sources are the information contained in research grant 
applications and grantees' progress reports. Members of the Institute 
staffs also couLribute importantly to the identification of opportunities 
within their field of responsibility. And conferences, symposia, colloquia, 
etc., concerned with appraising the current state-of-the-art, are addressed 
to evaluation and direction. Each year, as budget deadlines approach, 
the results of this quest for ideas are incorporated into a fiscal recom- 
mendation. 

For areas in which opportunities have been identified, funding recom- 
mendations are heavily conditioned by three factors: an assessment of 
relevance of the specific opportunity to the Nation's health; guestimates 
of the likelihood that its pursuit will be fruitful; and judgments on how 
large an effort is warranted by the intrinsic character of the opportunity 
under consideration. Not one of these assessments lends itself to really 
objective quantitative definition, and thus the NIH has come to rely 
heavily on the intuitive judgments of knowledgeable experts. 



13 

Limitations 

The degree of freedom in construction of the budget is limited. Past 
commitments cannot be ignored, and each year's budget cannot be written on 
a clear slate. Several of these limitations deserve mention. 

First, there are essentially mandatory obligations that the Nil! 
must recognize each year. One is the research grant with multiyear commit- 
ments. These arise because the task proposed in most applications 
necessarily takes longer than a year. Roughly 70 percent of the budgst 
for regular research-project grants is earmarked for these "moral conr?.it- 
ments," with the residual 30 percent for new grants. Nor can this latter 
group be viewed as entirely discretionary; it includes many renewal 
applications from distinguished and productive investigators pursuing 
important line, of investigation precisely in the mainstream of NIH 
statutory missions. 

'The protection of earlier long-range investments is another imperative, 
similar tc but extending beyond the period of "moral commitment." Certain 
types and styles of research require prolonged systematic exploration and 
will yield little exciting information in the interim. Continuance of 
these studies must be ensured until they have settled the issues they were 
designed to resolve. 

The intraneural research laboratories and clinics of the NIH, an 
extraordinarily fine center of biomedical research, cannot be subjected 
to rapid and capricious fluctuations without severely compromising its 
effectiveness. With unstable support, the attractiveness of the scientific 



14 

environment would be reduced and many of the most able members of the 
staff would soon leave. Moreover, good management recommends full use 
of the available laboratory space, built at great expense and useful for 
little but laboratory research. 

This is not to say that the intramural program is a sacred cow that 
cannot be touched. Considered accommodations are always possible, and 
indeed constantly occur as part of the natural development of programs. 
Still, the intramural research must be accorded an extremely high priority 
claim on budgetary resources. 

Inflation also has to be recognized as an important factor, for which 
the fixed commitments of the NIH must be adjusted. Since about 1967 the 
impact of, inflation has substantially eroded Liie amuunt of research that 
can be conducted at any given dollar level of expenditure. 

A number of other limitations also influence the framing of the NIH 
budget. Certainly, large-scale expansion cannot be undertaken suddenly, 
because of the need for trained manpower and for space. The lead time 
necessary to produce a Ph.D. is between five and ten years after receipt 
of the baccalaureate degree, and lead time for the production of modern 
laboratory space averages about three years from the time of groundbreaking 

Exploitation of certain types of research opportunity is limited by 
cost in a somewhat special way. For instance, a definitive study of the 
effect of diet 01 the process of atherogenesis , though often considered, 
would be so expensive in funds, time and manpower that wisdom has always 
recommended deferral. In other cases the political climate may affect 



15 

judgments on the advisability of exploiting opportunities. For instance, 
research avowedly addressed to contraception was for all practical purposes 
unsupportable by the NIH before about 1962. 

Budget Formulation 

Each year, then, the NIH, in the light of its statutory missions, 
constructs a biomedical research budget, assessing present and emerging 
opportunities and recognizing inescapable limitations. Yet another 
limitation, arising in later stages of the process, is the ceiling imposed 
on NIH by the DHEW in accord with the latter's ceiling imposed by the 
President — or practically speaking, the OMB. The final recommendations 
of the NIH then reflect the agency's best judgment, in terms of scientific 
and social merit, as to the proper allocation of the resources that the 
President and the Department are willing to provide. 

The budget for next year is one thing; a five-year budget projection 
is a considerably different matter. The discretionary funds actually 
available in a single year are small, as a result of the large amount of 
money that must be spent to sustain ongoing programs and to honor prior 
commitments. But estimates of such commitments become progressively 
softer for each future year. Moreover, the capability to foresee 
opportunities is severely circumscribed by the very nature of research. 
Thus inherent uncertainties tend to reduce long-range budget forecasts to 
an arithmetic exorcise, with only a small fraction of the total reflecting 
predictable costs of current long-range commitments. 



16 

The Disposition of the MIH Budget Recommendations 

The budget proposed by the NIH is reviewed within the Executive 
Branch by the DREW and the OMB. Within the ceilings imposed, specific 
budgetary proposals must be acceptable to higher authority. 

The focus of the DHEVJ review is in the broad context of health. 
The Department seeks assurance that the proposal, viewed in the light of 
submissions from other health agencies within the DHET. 7 , reflects the most 
well-balanced and productive allocation of funds. Cognizance is taken of 
other Departmental goals — education, welfare — and addresses- the question 
of optimal balance among all these missions. 

The OMB review is also focused on intrinsic merit and balance. Its 
scrutiny, however, is in terms of the President's grand strategy, and its 
purview encompasses all health activities across the entire Federal scene. 
Beyond this, the OMB views the total national research budget and certain 
important subsets, such as the national budget for academic science. After 
extensive negotiations with the Federal agencies, involving all sorts and 
varieties of trade-offs, the OMB prepares the Executive Budget which the 
President transmits to the Congress. This document embodies the President's 
interpretation of his electoral mandate. 

Next the budget proposed by the President undergoes lengthy and 
searching review by the appropriations committees and subcommittees in 
the House of Representatives and the Senate. It is defended by knowledgeable 
program operators, and a large number of nongovernmental witnesses are 
allowed to testify. The Congressional focus is principally on the social 
merit of the proposed expenditures, even though a serious effort is made 



17 

to obtain a balanced appraisal of the scientific status and promise of 
the fields under consideration. 

The outcome of the Congressional review is strongly colored by the 
interests and commitments of the subcommittee chairmen and members, as 
veil as by the scope of their responsibilities. For the last quarter of a 
century, the budgets proposed for the NIH have come before appropriations 
subcommittees deeply concerned with the Nation's health problems and 
convinced that research was vital to their solution. The recommendations 
of the subcommittees have usually fared well. Indeed, the~*Cofigress has 
frequently appropriated funds to the NIH in excess of those requested by 
the President. Increases include both specific earmarks for very narrow 
purposes and general increases in virtually all program areas. 

Conclusion 

In the light of the theoretical and practical considerations I have 
outlined, it is difficult to escape the conclusion that the issue posed is 
a matter of process rather than ideolog'j . While there may be a series of 
rough guides that place approximate quantitative bounds on budget proposals 
there are no operationally applicable principles that can be called 
normative. The ultimate decisions, the authoritative ones, are made 
through the political process by the political institutions of the Federal 
Government. 

The NIH role in this process, as I have pointed out, is to formulate 
a set of recommendations. The final decisions require the NIH to execute 
the budget in the best interests of its missions and objectives: that is, 



18 



to support the best research efforts that can be found within the purposes 
for which the funds were appropriated; to sustain the system for research; 
and to seek maximum stability of the national biomedical research enterprise, 
If the higher levels of the Executive or' the Congress desire a more or less 
intensive effort in a given field than was recommended by the NIH, the 
agency must, of course, accommodate. 

The national interest would be well served — as would also be the 
individual and institutional performers of biomedical research — if the 
Executive Branch would at least accept soze schedule of future funding as 
a target — one to be adhered to unless extraordinary events developed to 
force deviation. If the departmental five-year plan were to evolve in this 
uii'ecLiuu, NIK planning of research and research facilities and manpower 
would be enormous- ly facilitated. In advocating such a modus operandi, the 
NIH recognizes that the decision on funding level would be arbitrary. 
However, an arbitrary but certain target would be preferable to a flexible 
and uncertain one. 



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U SU,TE 20 °- ONE DUPONT CIRCLE. N.W., WASHINGTON. D.C. 20036 




JOURNAL OF MEDICAL EDUCATION 

WASHINGTON: 202: 466-5 



July 10,. 1973 



Thomas J. Kennedy, Jr. , M.D. 
Associate Director for Program 

Planning & Evaluation 
National Institutes of Health 
Department of Health, Education, 

and Welfare 
Bethesda, Maryland 20014 

Dear Dr. Kennedy: 



Communications ifyou ^£3 SnfSS S ^nsxder it for publication as a 
double-spaced ^^^^^^"2^ ££.. 

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of our readers 25 arp ™??Li? ? riI ? ) ' are fa ^ ili ^ in general to most 

Sincerely, 

%lU4f / *£ 'fax/ 



Merrill T. McCOrd 
Editor 



MTM:dh 



NIH RESEARCH PROGRAM-PROJECT 
AND CENTER GRANTS* 

Thomas J. Kennedy, Jr., M.D. ; Ann A. Kaufman, Ph.D.; 
John C. James, Ph.D.; and Solomon Eskenazi** 



An examination of the impact of research program-project and center 
grants upon academic health centers might well begin with an attempt 
to characterize the awards of this genre made by the National Institutes 
of Health, their principal source, and to review historical events 
anteceding the present situation. 

The Current Scene 
Tabulated in the first figure are four sets of frequency distributions 
by size of award. The first two columns show the distribution of NIH 
research project grants. The NIH has always attached tremendous 
significance to the grants in this category, which support the projects 
originated by investigators throughout the country, deemed by the NIH 
to be related to the mission of one of its institutes, reviewed 
objectively under the impartial auspices of the Division of Research 
Grants for scientific merit, and assigned a program priority by the 



♦Presented by Dr. Kennedy before the American Association of Medical 
Colleges, Washington, D.C., 3/29/73. 

**Associate Director for Program Planning and Evaluation, National 
Institutes of Health, U.S. Dept. of Health, Education, and Welfare; 
Research Grants Officer, Office of the Associate Director for Extramural 
Research and Training, NIH; Chief, Research Analysis and Evaluation 
Branch, Division of Research Grants, NIH; and Chief, Statistics and 
Analysis Branch, DRG, NIH. 



2 

National Advisory Council of the institute responsible for support of 
the application. These grants are the heart of fundamental biomedical 
research in this country, the fountainhead of scientific knowledge 
constituting the foundations upon which future progress depends. They 
tend to be small: 68 percent are below $50,000 and 95 percent below 
$100,000. About half of them, accounting for almost 40 percent of the 
dollars in this category, are funded at an annual level of $25,000 to 
$50,000. The situation is quite different for the other three types 
of award shown in the table. 

Research, "program project grants are larger, with about 90 percent 
in excess of $100,000. Seventy-seven percent are funded at levels of 
$100,000 to $500,000 and account for 60 percent of the funds. About 
10 percent exceed $0.5 million, with a few in excess of $1 million. 
Small program project grants — under $100,000 — accounted for only 2 
percent of the program project funds in fiscal year 1972. 

The general clinical research centers cluster between $300,000 
and $700,000. The interval encompasses 75 percent of the grants and 
67 percent of the funds. 

The other grants in this class, labeled for brevity as research 
centers t include a fairly wide variety of large and small operations 
distributed rather evenly over the whole range. The 84 grants under 
$100,000 — roughly one-third of the universe — include many that support 
animal resources. 

In terms of distribution by award size, the grants in the last 
three sets of columns are clearly different from the traditional research 



3 

project grants. They constitute the universe to be discussed 
henceforth. 

Figure 2 depicts the major classes of programs in this universe. 
The bars are proportional in length to the funding level in 1972, and 
the numbers at the left show the number of grants. There is a slight 
difference between the values shown in the chart and those in the 
previous figure (1) because of differences in the treatment of supple- 
mental awards,* but the discrepancies are insignificant for purposes of 
discussion. Research program projects are the largest single 
component, accounting for about 54 percent of the funds and 58 percent 
of the awards in the group. Ten species of center and other special 
grants are enumerated, including the first recognized — general clinical 
research centers — as well as the most recently created — sickle-cell 
anemia centers. 

The NIH has always been a highly decentralized organization, 
characterized by minimal central control and by delegation of much 
authority and discretion to its component institutes. As a result, 
within broad policy guidelines, wide variability in practice as between 
institutes has evolved. Generalizations about NIH programs axe 
dangerous, and it is necessary to look at each institute in order to 
fully grasp current realities. 



*So as not to distort the frequency distribution, supplements to 
previous years' grants "are excluded. 



4 

The next figure (3) shows the number and dollar-value of program- 
project and center awards funded by each of the institutes. Several 
institutes do not subdivide their program projects, while some identify 
specific subgroups. 

Center grants tend to have a strong clinical flavor, as in the 
case of the categorical clinical centers of the National Institute 
of Arthritis, Metabolism and Digestive Diseases, or reflect a sub- 
mission of an institute's overall goal, as in the allergic disease 
centers and transplantation/ immunology centers of the National 
Institute of Allergy and Infectious Diseases. 

Both the National Institute of General Medical Sciences and the 
National Institute of Child Health and Human Development tend to uti- 
lize program projects and centers for supporting research in their 
major domains of concern. For NIGMS, awards of both types support 
pharmacology/toxicology, genetics, anesthesiology, and diagnostic 
radiology. Trauma research has large clinical components — hence the 
centers — while the problems under attack in research on automated 
clinical laboratories, on the cellular basis of disease, on biomedical 
engineering, and on adaptation and behavior have a preponderantly 
laboratory flavor. NICHD sponsors activities in growth and development, 
perinatal biology/infant mortality, cell aging, population research, 
and mental retardation. The last two are supported under both types 
of award. 

The same patterns characterize the programs of the National Heart 
and Lung Institute and the National Institute of Neurological Diseases 
and Stroke, with the latter institute providing the greatest variety. 



5 
The largest investor in centers, both in dollars and awards, is 
the Division of Research Resources, formerly the Division of Research 
Facilities and Resources (and earlier still, a component of NIGMS). 
These programs, wherever organizationally located, were the first centers 
on the scene, and embody one very important element of many large 
grants: a central core of resources — equipment such as beds or computers 
or primates, and special types of personnel such as dieticians, computer 
programmers, primatologists, or metabolic unit nurses — for a broad 
program of research. 

This, then, was the scene in August 1972. The NIH was funding 
807 program projects and centers for $290 million, through all of its 
institutes and research divisions, under a wide variety of names and 
types. Over the fiscal year 1972, as shown in Figure 1, the NIH awarded 
825 of these special grants for $293 million. 

History 
Historically, how did we get here? In the late 1950s two in- 
adequacies in the machinery for the Federal support of biomedical 
research surfaced. The first of these related to and, we suspect, was 
precipated by the emerging strength and increased capability created by 
a decade and a half of exuberant growth. The need to coordinate and 
integrate related research within many grantee institutions became 
apparent. Particularly important from the point of view of the 
institution was the need or desirability to pool equipment, to share 
facilities and resources, to utilize more fully technical and supportive 
personnel, and finally, to bring an end to the bookkeeping nightmare 



6 

of prorating the cost of animal facilities, technical aides, secretaries, 
equipment, and supplies against multiple grants when, de facto } they 
were used commonly by a group of principal investigators on several 
research projects. 

From the NIH point of view, the thematic interrelationship of 
many projects within a grantee institution to the mission of the funding 
National Institute, and the presence — usually — of one or two scientists 
in acknowledged leadership roles, emphasized that this group of projects 
really constituted a coherent program with structured scientific and 
intellectual leadership, rather than a simple collection of random 
research projects in a single locus. Accordingly, the NIH was on the 
verge of coining the term "program grant" to support such ventures 
vhen the Office of the General Counsel reminded us — in forceful and 
official terms — that our authority was limited to the award of project 
grants. The ensuing lengthy discussion of the word "project" eventuated 
in a compromise — the somewhat awkward semantic tag "program project." 

The other inadequacy in the armamentarium of NIH support mechanisms 
emerged from the difficulties experienced by clinical investigators 
in either financing metabolic units or in conducting metabolic balance 
studies outside such units. This led to requests that the NIH provide 
these units with basic logistical support, to a parallel advocacy 
before congressional appropriations committees, and to the eventual 
creation by the Congress of the General Clinical Research Center 
Program, together with a good legislative history for categorical 
clinical research centers. The erstwhile Director of the NIH, Dr. James 
A. Shannon, fought with his usual resourcefulness to keep all of the 



7 
clinical research in an institution limited to and focused in one discrete 
locus and supported through one single instrument. He feared that 
otherwise, there would be an endless proliferation and fragmentation, 
with high and unnecessary overhead costs and serious organizational 
strains in the grantee institution. He was opposed by articulate 
spokesmen from the scientific research community who emphasized the 
need for categorical visibility — i.e., heart disease, cancer — to ensure 
continued public recognition of the importance of the problem and to 
guarantee sustained support. As is clear from the previous figure, 
Shannon didn't win all the battles he engaged in. 

Without going too far back into history, let us review the fiscal 
evolution of the programs since 1967, in the context of the total NIH 
research program and in both absolute and relative terms. 

Figure A illustrates that NIH extramural research awards in toio 
grew from $685 million to $1,045 million. Fiscal 1972 was a somewhat 
exceptional year as a result of the marked expansion of the cancer 
program and the somewhat more modest but still exceptional increase 
for the National Heart and Lung Institute. Over this period general 
research support grants remained about constant, as did research project 
grants until last year. On the other hand, there was a parallel and 
steady growth, accentuated in 1972, of both program projects and centers. 
The latter, funded at $154 million in 1967, rose to the $296 million 
level. 

Figure 5 depicts this growth in terms of the proportion of NIH 
research support attributable to the several types of award. Program 



8 

project and center grants increased from 22.5 percent to 28.3 percent 
of all NIH extramural research support — a growth exceeded only by that 
of research contracts, which almost doubled. The research project 
grants now represent a decidely smaller fraction of NIH support than 
they did in 1967. 

Figure 6 tabulates the change in numbers of competing new and 
renewal awards since fiscal 1967, with the level for that year normalized 
to 100. The number of research project awards fell in 1968 and remained 
down until fiscal 1972, when it rose appreciably, approaching the 1967 
level. By contrast, the number of program projects and centers rose 
significantly over the period. Renewals increased almost threefold. 

Comparison of applications received by the NIH for new and renewal 
research grants reveals a similar pattern (Figure 7). After fiscal 
year 1967, the total of competing applications dropped; then those for 
research project grants rose in 1972 to 110 percent of the 1967 level, 
as compared with 216 percent for the program project and center grants. 

Nature of the Beast 
As one reviews the various documents discussing the conception, 
gestation, birth, and development of the activities supported under 
the title of program-project or center grants, there is little to 
gratify the theoretician's appetite for a rationale. Among the 
properties that were ascribed to the research characterized as ideally 
suited for support through these instruments were its multidisciplinary 
nature, its thematic or programmatic coherence, its unusually wide scope, 
its probable long-term course, and its need for stable logistical support, 



9 

What are the actual characteristics of the instruments at present? 
Recently, the Executive Committee on Extramural Affairs, NIH, chaired 
by Dr. Thomas E. Malone, surveyed the institutes to illuminate this 
question. 

Figure 8 reflects a bureaucratic concern, indicating which of the 
center grant programs warrant specific line items in the budgets of 
the several institutes. Six institutes reflect these programs in a 
total of nine budget line items. This information may interest those 
of you who are dedicated watchers of the annual budget documents. 

The data in figure 9 reflect some other characteristics of this 
universe of awards. In contrast to research project grants, of which 
the Division of Research Grants is responsible for most of the initial 
review, program project and centers grants are often, though not always, 
reviewed within the awarding institute. Moreover, they are subject 
to more frequent surveillance and more careful monitoring than 
research project grants, which typically are reviewed only at the end 
of the project period. 

Figure 10 displays the wide variation in practice between institutes — 
and actually within single institutes — with respect to the activities 
for which funds may legitimately be spent. For example, "core" support — 
the basic personnel, facilities, and resources — is prohibited in some 
awards, allowed in others, encouraged in many, and required in a few. 

Funds for support of discrete research projects in addition to 
core support may likewise be prohibited, permitted, encouraged, or 
required under the specific terms and conditions of awards from various 
institutes or their components. Similar variability characterizes 



10 
attitudes and policies under grants of this genre regarding the support 
of administrative or research staff, facility renovation, clinical 
beds, research or clinical training, and fees for service and subcontracts. 

Thus the program project and center grants appear to be quite 
heterogeneous in character, and in many cases the distinction between 
them is hard to discern, even within a single institute. 

There are certain properties, however, that emerge from analyses 
of DRG data which sharply differentiate awards of this type from 
research project grants, and may constitute grist for an issue as yet 
inchoately articulated. 

The next two figures (11 and 12) show, at two points in time, 
the distribution of support by age of grant for traditional research 
projects and for program projects and centers. Concentrating first 
on the right side — traditional research grants — there is an almost 
exponential decline in funds as projects age. In fiscal year 1967 
$68 million was in projects in their first year, $49 million in projects 
in their second year, $39 million in projects in their third year, 
etc., with only a small fraction in projects older than 10 years. No 
such attrition with aging is apparent for the special grants, with an 
almost equivalent amount in projects of all ages. Viewed A years 
later, in fiscal year 1971, the same general pattern prevails. 

These data are open to a variety of interpretations, but some 
would seem incontestable. Most research project grants terminate 
after a relatively brief time, and few extend beyond one or two rounds 
of renewal competition. Investigators wind up their projects in due 



11 

course and initiate entirely new ones; only rare ones continue to be 
productive and worthy of continued funding for extended periods. Program 
projects and centers, on the other hand, do not experience this pattern 
of attrition, at least over the period of examination. This 
observation suggests that within the broad boundaries of the grant, 
internal adjustments to purge the nonproductive, to expand the productive, 
and to create new ventures are possible. Thus, the programs continue 
to be relevant in a timely way to the concerns and goals of the funding 
national institute and to warrant continued support. 

Figure 13, in a sense, is another expression of the phenomenon 
just illustrated. The graphs compare the award rates — that is, the 
fraction of these grant applications approved by National Advisory 
Councils which are actually awarded — for research project grants and 
for program project and center grants. For both genres the renewal 
applications fare better than the new ones, with renewal program project 
and center grants, especially the largest ones, doing extraordinarily 
well. Whether the application be new or renewal, the award rates are 
almost always higher for the program project and center grants than 
for the research project grants. 

With respect to the dollars awarded (Figure 14), it is once again 
evident that a higher fraction of the approved dollars are awarded in 
program project and center grants than in research project grants. 
For example, in fiscal year 1972, about 80 percent of the approved 
dollars for the program projects and centers were awarded, while only 
65 percent of the research-project grant dollars were made available. 



12 
These data suggest that the special grants fare better in competition 
than the project grants. If so, why? and what does this condition imply 
for the grantee institution? 

Discussion 

Program project and center grants probably fare better because 
they approximate more closely the missions of the institutes as perceived 
by the officials in those organizations, and are more likely to yield 
information meeting requirements for Immediate, applicable results. 
Since these grants are large, the development of grant applications 
is a long and painstaking process, undertaken often under Federal 
stimulation, directed toward preselected institutions recognized 
as sites of unusual capability, and almost always in consultation and 
negotiation with the Federal agency. Initial scientific review is 
associated with, rather than divorced from, the awarding institute, 
and the National Advisory Council of the institute has often played 
an important role in stimulating the development of the program of 
which the application is, or is about to be, a component. 

From the NIH viewpoint, then, the program-project and center grants 
are available instruments with which to tackle a specific categorical 
mission, and hence should fare well in the competition for funds. The 
NIH also recognizes the role played by the academic institutions 
themselves as performers of biomedical research and as developers of 
research manpower, and is well aware that the viability and strength 
of these institutions is essential for a high-quality national research 
enterprise. From the Federal perspective, the relative stability of 
the special grants, combined with their capacity to support a substantial 



13 

fraction of the salaries of a significant number of faculty members, is 
viewed as a contribution to the stabilization and strengthening of the 
institutional framework. 

As to perceptions from the performer institution's side, there are 
many at this conference better qualified than we to offer facts and 
interpretations. We will limit our remarks to questions that seem, 
a priori and theoretically, to encompass matters of legitimate concern. 

Do problems arise in an academic institution from the requirement 
Imposed by large grants to match programs and goals so closely to those 
of a Federal agency? 

Is the institution's governance over its grantee components 
compromised? 

Is undue Federal interference in the destiny of the university 
introduced through the siren song of large dollar awards? 

Is the gain in stable support worth the trade-off, if such there 
is, in academic autonomy and independence? 

Is the stability real or apparent? Does the university have to go 
through less angst, stum and drang, etc., to ratify the reprogramming 
of activities and the replacement of personnel so necessary to guarantee 
the stability of the special grant than it would in adjusting to the 
ebb and flow of regular research grant funds? 

Can an academic institution become saddled with an activity that, 
however grand for the Federal Government and for national goals, is out 
of line with its own current aims, objectives, and aspirations? 

These are some of the questions that arise in any consideration 
of the impact of program projects and centers, particularly in regards 
to their competition with traditional research project support. 





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Inst itu te 
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Eye 



Environmental 
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Figure 3 

NIH RESEARCH PROGRAM PROJECTS AND CENTERS 
AS OF AUGUST 1972 

(Dollars in Millions) 

Type of grant 

Program projects 
Allergic disease centers 
Transplantation/ immunology centers 

Program projects 
Categorical clinical centers 

Clinical research centers 
Preclinical research centers 
Exploratory studies for centers 

Program projects 

Categorical clinical research center 

Dental research institutes 

Program projects 
Research centers 
Outpatient research centers 



16 



Program projects 
University-eased centers 



NUMBEF 


: Amount - 


7 


$ 2.4 


9 


.6 


3 


,5 




$ 3.6 


37 


8,4 


10 


2,2 




$ 10.6 


57 


28.9 


26 


19.7 


42 


4,2 




$ 52.8 


19 


4.7 


1 


.4 


5 


6,5 




$ 11.6 


10 


3.3 


2 


.3 


11 


.7 




_-_$ 4.3 


12 


3.7 


6 


3,9 




$ 7.6 




(Continued) 



17 



NIH RESEARCH PROGRAM PROJECTS AND CENTERS 
AS OF AUGUST 1972 (Dollars in Millions) (Cont.) 



In stitute 

General 
Medical 
Sciences 



Child 
Health 



Type of grant 

Pharmacology/toxicology p.p, 
Genetics & genetic chem. p.p. 
Anesthesiology p.p. 
Diagnostic radiology p.p. 
Automated clinical labs p.p. 
Cellular basis of dis. p.p. 
Biomedical engineering p.p. 
Adaptation & behavior p.p. 
Pharmacology/toxicology centers 
Genetics centers 
Anesthesiology centers 
Diagnostic radiology centers 
Trauma centers 



Population research program projects 
Growth and development p.p. 
Mental retardation program projects 
Perinatal bio/infant mortality p.p. 
Cell aging program projects 
Population research centers 
Mental retardation centers 



Number Amount 



9 


$ 2.0 


M 


5.9 


2 


.9 


3 


1.2 


5 


1.7 


8 


2.2 


11 


1.0 


2 


.7 


12 


6.4 


7 


A. 6 


4 


3.2 


2 


1.1 


8 


IA 




% 35.3 


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11 


2.2 


21 


6.1 


8 


1.9 


— 9 

5 


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5 


1.3 


12 


5", 6 




$ 19.8 




(Continued) 



18 



I nsti tute 
Heart 



NIH RESEARCH PROGRAM PROJECTS AND CENTERS 
AS OF AUGUST 1972 (Dollars in Millions) (Cont.) 



Type of grant 

Program projects 
SCOR — arteriosclerosis centers 
scor — hypertension centers 
scor— pulmonary disease centers 
scor— thrombosis centers 
Comprehensive sickle cell centers 



Number 

76 
15 

5 
17 

5 
10 



$ 



Neurology 



Gen, neuro. disorders p.p. .8 

Chronic neuro, disorders p,p, 1 

Sensory and perceptual disorders 7 

'Disorders of hearing p.p. . 5 

Nerve injury and regeneration p.p, 2 

Gen. neuro, disorders centers 2 

Cerebrovascular disorders centers 15 

Head injury clin, research centers 5 

Acute sp, chord injury clin. res, ctrs, 6 

Convulsive disorders clin. res, ctrs. 3 
SENSORY/ perceptual disorders cl. r. ctrs, 3 

Chronic neuro, disorders cl. r, ctrs, 3 

Disorders of hearing clin. res, ctrs, 1 

Outpatient clin, res. centers 4 

Muscular and neurom. clin. res. ctrs, 5 



(Co mt. 



19 

. NIK RESEARCH PROGRAM PROJECTS AND CENTERS 
AS OF AUGUST 1972 (Collars in Millions) (Cont.) 

Institute Type of grant Number Amoun 

Research Biotechnology resource centers 
Resources Primate research centers 

Animal colonies/ animal model dev. 

Animal resource diagnostic labs, 

Inst, animal resource improvement 

General clinical research centers 



40 


$ 10, H 


7 


11.2 


29 


2.1 


16 


l.i 


23 


2.1 


83 


_J2o2 




$ 69,1 



Figure 4 



20 



FUNDS AWARDED FOR NIH RESEARCH GRANT AND CONTRACT 
PROGRAMS, BY TYPE OF PROGRAM, FY 1967-1972 



MILLIONS 
$ 1000 — 



800 



600 



400 



200 



$ 685.2 



•:: : :;872$:: 




$ 722.2 




S 96.2:;: 




$732.1 



ml- 



■y. I04.5W 

>::J£5.3:: : ::: 

^RESEARCH CONTRACTS 



$707.5 



1% 



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|54.2^ 




^^ 



155.88; 




$ 1,045.0 



1240.0 >S 





1 295.85 



1967* 1968 



1969 



1970 



1971 



1972 



*BHME AND NLM ARE INCLUDED FOR COMPARABILITY, THOUGH NOT CONSTITUENTS OF N I H UNTIL 
APRIL 1968. 



Figure 5 



21 



PERCENTAGE DISTRIBUTION OF FUNDS AWARDED FOR NIH 

RESEARCH GRANT AND CONTRACT PROGRAMS, BY TYPE 

OF PROGRAM, FY 1967-1972 



(DOLLARS IN MILLIONS) 




1967* 1968 



1969 



1972 



*BHME AND NLM ARE INCLUDED FOR COMPARABILITY, THOUGH NOT CONSTITUENTS OF NIH 
UNTIL APRIL 1968. 



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In 1947 NIH first formed an Office of Research Planning. The 
activities of this office were relatively modest — collecting, dis- 
seminating and publishing operating statistics on the research effort 
supported by the agency. In 1957, when Herb Rosenberg's organization 
was formed, the scope of activities was expanded to encompass a national 
view. 
Planning in a Scientific Environment 

"Planning" in scientific endeavor has a range of meanings that 
extend from curiosity-oriented basic research to systems realization 
or to an advanced stage of systems development. At different points 
on this range, planning has different connotations. For example, 
the ultimate character of an expected solution to the problem of aging 
could hardly be specified in concrete terms. On the other hand, 
expectations may at times be quite specific — e.g., a vaccine of 
describable properties. Thus, "planning" can mean very different 
things, depending on what type of problem is addressed. 

Another ambiguity relates to the extent to which elements of 
a plan or program are integrated into a coherent unity. So long 
as the focus is on individual projects in basic research, a degree 
of clarity is possible. Individual scientists have definite plans 
for actions to be undertaken each day in their laboratories. But 
it is almost impossible in basic research to foresee the pivotal 
points at which intermediate or final solutions will occur. A 
science administrator supervising this type of loosely defined 
activity usually follows a strategy of giving each investigator 



The above was given as a speech by Dr. Thomas J . Kennedy, Jr. on 
June 4, 1973. It is a Keynote address for the Program Planning 
Session sponsored by the STEP Committee, NIH. Topic: Staff 
Training for Extramural Programs. 



3 

The best measure of priorities is the dollars allocated to the 
several programs in an organization. The allocation must reflect the 
"state of the art" — the scientific opportunities that exist — as well 
as the social importance of the problem — its public health significance. 
These aspects are referred to in some of the readings as part of an 
element in the collective preference profile. Scientific opportunity 
and importance of the problem can be objectively analyzed in terms of 
mortality and morbidity rates, age of the affected population, and 
the state of knowledge. These are clearly real-world considerations. 

But once some of these parameters are identified and the specific 
problem is described, one begins to get into a complex calculus. 
Which is more important, a disease that is universally lethal but 
affects only a few people, or a disease of moderate severity that 
affects many people? Should effort be concentrated on people over 
60 whose life expectancy is limited or on those in the early stages 
of life? These subjective elements hinge on what Alvin Wineberg 
talked about as the internal and external criteria for the worth of 
scientific activities. Why does a scientist or mathematician feel 
that of half a dozen possible proofs for a theorem, one is the most 
worthy? This element of subjective judgment, or taste, if you will, 
plays a large role in decisions about both the state of the art in 
science and the importance of problems. Institute directors make 
their personal marks on. programs by their intuition in such matters. 

At higher organizational levels, the tendency is to accept 
with minor reservations the technical assessment and recommendations 



4 
of the plan's originators. The reviewers then attempt to regard these 
assessments and recommendations as part of a larger problem set, in 
which the choices should be guided by a broader consideration of public 
interest and aspirations. 

The emphasis at the level of the Office of the NIH Director is 
on developing, maintaining and updating a fiscal plan for NIH activities, 
The essential process for accomplishing this function is the allocation 
of marginal physical resources. Allocation decisions are influenced 
by consideration of program balance and by review of the significance 
of specific problems in a larger matrix of health missions. 

Program balance has received a lot of recent attention. It has 
a number of aspects, and balance by category of disease is one of 
these. This is frequently reduced to an organizational question of 
balance between the institutes, which is more than a budgetary matter 
because each institute has its own constituency of grantees, scientific 
societies, voluntary agencies and so forth. The problem here is to 
6eek optimal resource allocation within a framework provided by the 
realities of existing organizational boundaries. Perfect balance is 
an ever-moving but rarely reached target. 

Another element in program balance relates to the question of who 
is directing research — whether it is Federally initiated or comes 
from the scientific community. Other elements include: the detail 
to which research objectives are specified — fundamental vs. applied 
research, or the degree of targeting; the extent to which research 
is supported through grants, through contracts and through direct 



5 
investigation by Federal employees; and the degree of investment in 
short- vs. long-term efforts. 

The Office of the Director — in an attempt to define a national 
"collective preference" — must weigh the relative importance of the 
problems and opportunities that appear in the budget requests, the 
fiscal plans of the individual institutes, and the ways the plans of 
those institutes compete with one another. To accomplish this, the 
Office of the Director develops an NIH fiscal plan based on a synthesis 
of the scientific and fiscal plans presented by the several institutes. 
The NIH plan is defended at higher levels against the competing plans 
of other elements within the DREW. 

A second planning activity is to identify issues that transcend, 
or are shared by, the bureaus, institutes and research divisions and 
to develop "issue papers" relevant to them. One such issue recently 
examined was the appropriate level of funding for research in the 
United States. Once common problems have been identified, general 
solutions are sought. In one instance, a program to support construction 
of health research facilities emerged when a task force made up of 
Dr. K. M. Endicott from the OD staff and members of the several 
institutes found in a survey of academic institutions that there was 
virtually no remaining research space. As a result, the members 
recommended that NIH set up a program to assist academic institutions 
in providing such space. A more recent general solution to an 
issue was the Career Awards Program. This was developed in answer 
to the problem shared by NIH and the academic community of keeping 



6 
people in research and in academic institutions in order to train 
research workers. The solution was mutually satisfactory. Still 
another example was the development of the General Research Support 
Program in 1960 and, just before that, the development of the General 
Research Centers Program to meet a mutual need of all the NIH institutes 
and the community of research performers. 

A third planning activity at the Office of the Director's level 
is the identification of data elements of general interest or utility 
for planning. Once the elements are identified, the data must be 
collected, analyzed and distributed. An example is the annual survey 
of Federal expenditures for biomedical research. Other examples are 
national manpower surveys (how many people are in training? in what 
fields? at what level in graduate school? and to what extent is the 
Government supporting them, etc.). A final example is the data 
obtained for specific subsectors of the performing community, such as 
the survey for the Committee on Academic Science and Engineering 
of the Federal Council for Science and Technology, which catalogs 
Federal, DHEW and NIH support to academic institutions for all 
academic purposes. 

Planning at Higher Levels 

At levels higher than NIH, the process of planning places less 
emphasis on technical questions and the state of the art but confronts 
a much longer list of possible choices. The criteria for choice 
involve social preference, and the decisions reflect much more the 
political process. Clearly, at the level of the Office of the Secretary 



7 
for Health, the range of choices is enormous. All plans for NIH must 
be considered against those, for example, of the Food and Drug 
Administration. It is interesting to speculate on whether the Assistant 
Secretary could modify agency plans or express preferences by viewing 
the NIH as one unit in competition with all other units under his 
control, or whether he could consider each NIH program in competition 
with all others in health, attempting for example to consider the 
merits of supporting the biology of the hepatitis virus against those 
of providing additional inspectors for the Food and Drug Administration. 
Practically, the problem cannot be handled in detail. At the level 
of an Assistant Secretary, judgments must be made between large blocs 
of money. Hopefully in the iteration of the processes, the distribution 
within the agencies and their subcomponents will be suitably adjusted. 
At the level of the Secretary the list of choices becomes even longer, 
and estimating what the public really wants and at what price becomes 
more difficult. At the level of the Office of Management and Budget, 
the problem is mind-boggling. 

Yet several general statements can be made. For one, that process 
is as important, if not more so, than theory or ideology. To order 
objectively the many value conflicts inherent in budget formulation 
is clearly impossible. Questions of great significance are thus 
resolved in a somewhat disorderly and illogical manner. A certain 
openness characterizes the tentative judgments represented in the 
President's budget. All parties concerned have the opportunity to 
state their views in the course of congressional hearings. Then 



8 
somehow a resolution that comes close to doing what the public wants 
to have done with its funds emerges. 

A second general statement is that there is a limited degree of 
freedom at every level. Many uncontrollables must be recognized. The 
uncontrollables peculiar to the NIH are our moral commitments. At 
higher levels, there are items uncontrollable by law — statutes under 
which we provide for formula payments to individuals, organizations 
or political jurisdictions (Social Security, aid for dependent 
children, etc.). Since these uncontrollables must be included in the 
budget each year, and as long as the total budget is relatively constant, 
increases in the uncontrollables reduce the amounts available for 
discretionary expenditures. Moreover, "sacred cows" are found in the 
budget at every level. For example, whatever merit one attaches to 
the amount of money in special programs such as sickle cell anemia or 
Cooley's anemia, it is politically unthinkable to touch them at this 
time. As a result of these phenomena, the margin for change is much 
smaller than the overall size of the budget. As a corollary, major 
changes must be effected over a substantial length of time. 

A third general statement is that it is easy to become cynical 
about this process, particularly when you sit in the front office at 
NIH and see events suddenly emerge to make a mockery out of a year's 
work. Sudden decisions to double budgets in certain areas or to 
eliminate programs make one feel that all the rational analysis has 
been futile — that the whole business of planning is nothing but a 
game of politics, and one is a helpless actor on a very large stage 



9 

with a very small part to play. On the other hand, someone working in 
this field can only develop as logical and rational a basis as possible 
for the domain for which he is responsible. It may not always carry 
the day. I think that most planners feel that: they get up to bat 
frequently; their batting average is low, with many strike-outs; and 
every now and then they hit one out of the park. These occasional 
triumphs constitute the real pleasure that rewards the planner's 
labors. 



/ - 



OUTLINE 3 
W.T. Carrigan 

5/11/73 



PROSPECTS FOR REDERAL SUPPORT 
OF BIOMEDICAL RESEARCH* 

Thomas J. Kennedy, Jr., M.D.** 



I. An attempt to assess the prospects for Federal support of 

biomedical research might well focus primarily on the research 
award programs of the National Institutes of Health, which is 
the major contributor to medical research in this country and 
a bellwether among supportive Federal agencies. 



II. First, however, I'd like to show you a chart — the first slide, 
please: all obligations for biomedical R&D in the United States 
since 1960. 

A. The bars indicate that medical research has grown apace. 

B. There has been a remarkable consistency between the public 
and private sectors for at least a decade. 

C. The bars, however, overstate the growth in real terms. At 
1967 prices, we could have bought the R&D represented by the 
heavy lines — more prior to 1967 and less since then. We see 
that there have actually been gains (in the aggregate) despite 
inflation. 



III. NIH, in 1972, funded 38 percent of all U.S. biomedical research 
and about 60 percent of the Federal. The next slide (2) shows 
the relative importance of NIH programs in three universes of 
Federal support. NIH accounts for — 

A. 8 percent of all Federal R&D, 

B. 40 percent of Federal Funds for R&D at educational 
institutions, and 

C. 37 percent of Federal funds for academic science — R&D, 
training, facilities, and resources. 



*Prepared for delivery before the Society of Developmental Biology, Inc., 
Manhattan, Kansas, 6/15/73. 

**Associate Director for Program Planning and Evaluation, National 

Institutes of Health, U.S. Dept. of Health, Education, and Welfare. 



IV. The budget for FY 1974 will bring major changes in the way NIH funds 
are deployed. Slide, please (3). 

A. The program balance will shift in terms of — 

1. Areas of study, or health problems emphasized, and 

2. Program strategy — that is, degree of central direction — as 
indicated by instruments of support. 

B. The slide represents the 1974 President's Budget for the NIH 
institutes and research divisions, by program (appropriations), 
showing the 1973 and '74 columns and the change. 

1. The institutes and research divisions would rise $48 million, 
net. 

2. An upward trend in cancer and heart continues, while all 
the other programs decline. 

3. The severest cut is in the National Institute of General 
Medical Sciences — competing project grants. 

4. Most of the cut in the Division of Research Resources is 

in general research support grants (formula grants to insti- 
tutions), which are to be drastically scaled down. 

C. The next slide (4) turns the budget around to show the composite 
activity structure. 

1. Research training is being phased out in favor of a "free 
market" for graduate education. The Administration takes 
the position that medical R&D funds should suffice to attract 
students into the field, even to the extent that they would 
finance their own advance education. The Government may 
assist by underwriting loans. 

2. Total NIH research funds — grants and direct operations — 
would rise from $1,281 million for FY 1973 to $1,352 million 
for '74 — a 5 percent increase. 

a. The lion's share of the increase — $45 of $71 million — 
would go for R&D contracts, particularly in cancer and 
heart, 

3. It should be -pointed out that the increased use of contracts 
is not necessarily detrimental to basic research. 

a. In the institutes totally, as shown in the next slide (5), 
two-thirds of the research contract funds are going to 
nonprofit institutions — 45 percent to schools. Only a 
third are going to industry. 

b. The next slide (6) shows that cancer is exceptional in 



awarding only 52 percent of its contract funds to the 
nonprofit sector. 

c. In the cancer and heart institutes, contracts are being 
used increasingly to support basic investigation as well 
as developmental efforts.. 



Within the institute programs, there are major trends that we night 
examine more closely. 

A. I have already mentioned one, illustrated in the next slide (7): 
the expansion of the cancer and heart programs, which together 
account for nearly 50 percent of the 1974 research and training 
budget. This is the shift in health problem emphasis. 

1. Some of the current "targeted" programs are identified in 
the next slide (8). 

2. There is a tendency for certain programs to be protected as 
a result of special legislation, earmarking of funds, etc. 
As shown in the next slide (9), these tend to fare better 
than other biomedical research. 

B. Another trend, shown in the next slide (10), is the increasing 
use of R&D contracts and special, larger grants — namely, program- 
project and center grants. This is the shift in instruments 

of support. 

1. A percentage distribution of the same data, as shown in the 
next slide (11) , reflects the aggregate rise in relative 
importance of the targeted programs. Research contracts 
and centers are big business now at NIH. 

2. The next slide (12) shows rather dramatically how this 
change is distributed by institute. It is very strongly 
attributable to programming in cancer, in heart and lung, 
and in child health and human development. 

a. Note that there is also some absolute growth in the 
regular, or research project, grants in the three 
unusual institutes. 

b. The aggregate programs of the remaining institutes 

will decrease by 10 or 11 percent between FY 1972 and '74, 

c. The next and last slide (13) — again a percentage 
distribution of the same data — points up the contrast 
between the two groups of programs. 



C. Thus we see two forces affecting program balance: 

1. Certain institutes — mainly cancer, heart and child health — 
are moving, by means of contracts and special grants, 
toward targeted or applied research, with more central 
direction, more mission orientation, more relevance to 
socially important health problems. 

2. The other institutes continue in the vein of more evenness 
between directed, applied approaches and undifferentiated, 
basic science. 

3. This percentage distribution highlights the differences in 
approach. Lights, please. 



VI. Some further implications: The NIH is in the process of transforming 
its research apparatus. Within three of the institutes particularly, 
a different approach to research — stronger central direction — is 
manifest. They are changing their way of doing business. 

A. One effect of the special grants is that larger segments of the 
NIH program are amenable to local control at the institutional 
level. 

B. These trends in research support are consistent with policy 
stated as early as July 1967 — a policy of identifying oppor- 
tunities for applied, or targeted, research and of mounting 
programs to exploit them. 

C. On the other hand, it was not envisioned that cancer and heart 
research would be advanced at the expense of equally productive 
efforts against other diseases. 

D. We are back to the matter of program balance: given a limited 
sum of money, how should it be deployed (1) over the Nation's 
health problems and (2) with what degree of central control? 

1. There is no right or wrong answer — only one of consensus 
in terms of scientific and administrative judgment. 

2. Your direct expression, either to us or through your 
scientific societies, would be valuable. 

E. It may be safely predicted that as programs mature in all the 
institutes, a shift toward contracts and center grants, with 
a view to advancing Federal missions to conquer disease, will 
be the shape of things to come. 



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NIH INSTITUTES AND RESEARCH DIVISIONS 
FY 1974 PRESIDENT'S BUDGET* 
Summary by Program, Obligations in Thousands 



Total 



Cancer 

Heart 

Dental 

Arthritis 

Neurology 

Allergy 

General medical sciences 

Child health 

Eye 

Environmental health 

Research resources 

International center 



1973 


1974 


Change 


1,483,648 


$1,531,776 


+48,128 


426,400 


500,000 


+73,600 


247,075 


265,000 


+17,925 


40,333 


38,452 


- 1,881 


139,806 


133,608 


- 6,198 


105,539 


101,198 


- 4,341 


100,726 


98,693 


- 2,033 


151,587 


138,573 


-13,014 


109,551 


106,679 


- 2,872 


33,797 


32,092 


- 1,705 


25,889 


25,263 


- 626 


99,019 


88,632 


-10,387 


3,926 


3,586 


- 340 



♦2/16/73. 



NIH INSTITUTES AND RESEARCH DIVISIONS 

FY 1974 PRESIDENT'S BUDGET* 

Summary by Activity, Obligations in Thousands 



Total 

Research grants 
Regular programs 
Gen. res. support 
Other special grants 

Direct operations 
Labs & clinics 
R&D contracts 
Collab. res. 
Other direct 

Research training 
Training grants 
Fellowships 

Cancer control 

Cancer construction 



1973 


1974 


Change 


1,483,648 


$1,531,776 


+48,128 


812,415 

587,044 

26,124 

199,247 


826,518 
582,882 
.17,000 
226,636 


+14,103 

- 4,162 

- 9,124 
+27,389 


468,773 
117,933 
243,659 

48,888 
58,293 


525,264 

123,624 

288,241 

49,934 

63,465 


+56,491 
+ 5,691 
+44,582 
+ 1,046 
+ 5,172 


149,460 

112,783 

36,677 


125,994 
95,402 
30,592 


-23,466 
- 6,085 
-17,381 


4,000 


34,000 


+30,000 


49,000 


20,000 


-29,000 



♦2/16/73. 



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PERCENTAGE DISTRIBUTION OF NIH FUNDS 
for Research and Training, Excluding Programs Transferred Out* 
x Consolidated FY 1950-1974(Est.) Appropriations 



„ n ^w ^j^ GENERAL^?; \ }% 




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30H 

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10 




1950 '55 '60 '65 

•Excludes NIMH, DBS, community programs, and construction. FY 
1973 and 1974 from 1974 President's Budget of 1/15/73. tDRG, 
NIGMS, DRR, GRS-NIH. 



NIH FUNDS OBLIGATED FOR 

SELECTED "TARGETED" PROGRAMS, 

FY 1973 

(In thousands of dollars) 



Institute 



NCI 



NHL I 



NICHD 



Program 

Cancer Chemotherapy 
Special Virus Cancer 
Chemical Carcinogenesis 
Cancer Task Forces 

Arteriosclerosis 
Heart Co-op. Drug 
Sickle Cell Disease 
Medical Devices 



NIDR 


Dental Caries 


NIAMDD 


Artificial Kidney/ 




Chronic Uremia 


MNDS 


Collaborative 




Perinatal 


MAID 


Interferon/Anti viral 




Immunoprophylaxis 



Population Research 



TOTAL 



Contracts 


Other 

$16,508 


Total 


$40,555 


$57,063 


42,204 


6,855 


49,059 


22,649 


3,584 


26,233 


12,371 


4,661 


17,032 


25,457 


• 68,124 


93,581 


500 


4,900 


5,400 


5,761 


9,239 


15,000 


11,572 


600 


12,172 



3,559 
4,319 

3,500 

900 
3,000 

15,009 
$ 191,356 



5,138 



601 



1,926 

5,504 
3:,165 

24,835 



$155,640 



8,697 
4,920 

5,426 

6,404 
6,165 

39,844 

$346,996 



GROWTH OF SPECIALLY 
PROTECTED NIH PROGRAMS, 
FYs 1968 AND 1973 EST.* 

(Dollars in millions) 



Total NIH research 
Protected programs, total 

NCI, total 

Cancer chemotherapy 

Cancer virology 
NHLI, total 

Arteriosclerosis 

Sickle cell disease 
Dental caries 
Digestive diseases 
Child health 
Population/reproduction 
Aging 

All other biomedical research 

— of which: 

NIAMDD less dig. dis. 

Arthritis 

Cystic fibrosis 

Diabetes 
NIAID, total 
NIGMS, total 

Fundamental science 
NIEHS 



1968 

$ 1,066.9 

423.7 

183,4 
T26TT) 
(19.5) 
1 68.0 
31.8) 
0.9) 
1.0 
13.3 
36.6 
13.5 
8.0 

643.2 



131.9 
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2.0) 
7.5) 
94.4 
160.3 
(743) 
17.3 



1973 

$ 1,483.6 

803.9 

426.4 
T57TT) 
(49.1) 
247.1 
T9X6) 
(15.0) 
8.7 
16.2 
53.4 
39.8 
12.3 

679.7 



% change 

39% 

90 

132 
117 
152 

47 

194 

1567 

770 

22 

46 
195 

54 



123.6 


-6 


(14.2) 


28 


( 2.6) 


30 


( 7.4) 


-1 


100.7 


7 


151.6 


-5 


(57.1) 


-23 


25.9 


50 



includes research training, 



$1,200-t 



1,000 



200- 



*FY 1973 and 1974 from President's Budget of 2/16/73, 



FUNDS OBLIGATED FOR NIH RESEARCH 
GRANTS AND CONTRACTS, FY 1967-197^ 

(Dollars in millions) 



CONTRACTS 




1967 '68 



ft Y rt 



f/ 



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(Dollars in millions) 



% 

100 



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CONTRACTS 




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FUNDS OBLIGATED FOR NIH RESEARCH GRANTS AND CONTRACTS 
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>FY 



1967 '68 '69 '70 '71 '72 '73 '74 
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DIRECTOR'S ADVISORY COMMITTEE 

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Dr. Thomas J. Kennedy 

6/26/73 




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GRS 



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PERCENTAGE DISTRIBUTION OF FUNDS OBLIGATED 
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Allergy 



Arthritis 



Cancer 



Dental 



Eye 



Environmental 
Health 



NIH RESEARCH PROGRAM PROJECTS AND CENTERS 
AS OF AUGUST 1972 

(Dollars in Millions) 

• Type of grant 

Program projects 
Allergic disease centers 
Transplantation/ immunology centers 

Program projects 
Categorical clinical centers 

Clinical research centers 
Preclinical research centers 
Exploratory studies for centers 

Program projects 

Categorical clinical research center 

Dental research institutes 

Program projects 
Research centers 
Outpatient research centers 



Program projects 
University-based centers 



7 


$ 2,4 


9 


,6 


3 


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$ 3,6 


37 


8.4 


10 


2,2 




$ 10,6 


57 


28.9 


26 


19,7 


42 


4.2 




$ 52,8 


19 


4,7 


1 


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5 


6,5 




$ 11,6 


10 


3.3 


2 


.3 


11 


.7 




$ 4,3 


12 


3,7 


6 


3.9 




$ 7.6 


*»- 


(Continued) 



© 



NIH RESEARCH PROGRAM PROJECTS AND CENTERS 
AS OF AUGUST 1972 (Dollars in Millions) (Cont.) 



I nst i tut e 

General 
Medical 
Sciences 



Child 
Health 



Type of grant - 

Pharmacology/toxicology p,p, 
Genetics & genetic chem, p.p. 
Anesthesiology p.p. 
Diagnostic radiology p.p. 
Automated clinical labs p.p. 
Cellular basis of dis. p.p. 
Biomedical engineering p.p. 
Adaptation 8 behavior p.p. 
Pharmacology/toxicology centers 
Genetics centers 
Anesthesiology centers 
Diagnostic radiology centers 
Trauma centers 



Population research program projects 
Growth and development .p.p. 
Mental retardation program projects 
Perinatal bio/infant mortality p.p. 
Cell aging program projects 
Population research centers 
Mental retardation centers 



Number Am oun t 



9 


$ 2.0 


14 


5.9 


2 


.9 


3 


1.2 


5 


1,7 


8 


2,2 


11 


4,0 


2 


.7 


12 


6,4 


7 


4,6 


4 


3.2 


2 


1,1 


8 


2,4 




$ 36.3 


9 


2.0 


11 


2.2 


21 


6.1 


8 


1.9 


3 


.7 


5 


1.3 


12 


5,6 



$ 19.8 
(Continued) 




ft 3 



NIH RESEARCH PROGRAM PROJECTS AND CENTERS 
AS OF AUGUST 1972 (Dollars in Millions) (Cont.) 



Inst itut e 
Heart 



Neurology 



Type of grant 

Program projects 
sc0r--arteriosclerosis centers 
SCOR — hypertension centers 
scor— pulmonary disease centers 
scor— thrombosis centers 
Comprehensive sickle cell centers 



Gen, neuro, disorders p.p. 
Chronic neuro, disorders p.p. 
Sensory and perceptual disorders 
Disorders of hearing p.p. 
Nerve injury and regeneration p.p. 
Gen, neuro, disorders centers 
Cerebrovascular disorders centers 
Head injury clin, research centers 
Acute sp, chord injury clin, res, ctrs, 
Convulsive disorders clin, res. ctrs, 
Sensory, perceptual disorders cl. r, ctrs 
Chronic neuro, disorders cl. r. ctrs, 
Disorders of hearing clin, res, ctrs, 
Outpatient clin, res, centers 
Muscular and neurom, clin, res, ctrs, 



Number A mount 



76 


$ 34,5 


15 


9.5 


5 


2,9 


17 


5.5 


5 


1.6 


10 


4,8 




$ 58.8 


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5 


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2 


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1,1 


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$ 15.6 


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NIH FUNDS OBLIGATED FOR 

SELECTED "TARGETED" PROGRAMS, 

FY 1973 

(In thousands of dollars) 



Institute 



NCI 



NHL I 



NIDR 
NIAMDD 

NINDS 

NIAID 

NICHD 



Program 


Contracts 


Other 


Total 


Cancer Chemotherapy 


$40,555 


$16,508 


$57,063 


Special Virus Cancer 


42,204 


6,855 


49,059 


Chemical Carcinogenesis 


22,649 


3,584 


26,233 


Cancer Task Forces 


12,371 


4,661 


17,032 


Arteriosclerosis 


25,457 


68,124 


93,581 


Heart Co-op. Drug 


500 


4,900 


5,400 


Sickle Cell Disease 


5,761 


9,239 


15,000 


Medical Devices 


11,572 


600 


12,172 


Dental Caries 


3,559 


5,138 


8,697 


Artificial Kidney/ 
Chronic Uremia 


4,319 


601 


4,920 


Collaborative 
Perinatal 


3,500 


1,926 


5,426 


Interferon/Anti viral 


900 


5,504 


6,404 


Irmiunoprophylaxis 


3,000 


3,165 


6,165 


Population Research 


15,009 


24,835 


39,844 


TOTAL 


$191,356 


$155,640 


$346,996 






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A 



AN EXPERIMENTAL ALTERNATIVE TO PROGRAM PROJECT AND CENTER GRANTS 

In the last decade or so, and particularly in the last five years, 
the absolute level of investment in program project and center grants 
has increased substantially and, in at least three institutes (NCI, 
NHLI, and NICHD) , the fraction of the institutes' budget devoted to 
the support of research through these instrumentalities has increased 
significantly. 

Very substantial advantages and advances can be attributed to the 
introduction of this administrative innovation. After a decade of solid 
experience, the NIH has been in the process of reviewing the effective- 
ness of these mechanisms of support. The institutes view them as 
extremely valuable and powerful tools in achieving their categorical 
missions, and grantee institutions also appear to regard them as very 
useful. On the other hand, some problems have emerged for both the 
NIH and the grantees. 

The Problem 
In the grantee institutions, difficulty has been experienced in 
exerting administrative surveillance over very large-scale activities 
as well as in reconciling the activities and personnel supported under 
the grant with the overall short- and long-term objectives of the 
institution. From the point of view of the NIH, the central problem 
has been to insure a quality review of large and complicated proposals, 
consisting of many projects under the guidance of many investigators. 



Since these proposal are frequently characterized by a broad spread in 
the imaginativeness of component parts and in the competence of individual 
investigators, the assigned priority score is a composite of many 
elements and thus is difficult to interpret. Moreover, the nature of 
the aggregated proposal characteristically dictates the need for long-term 
support, so that new projects and new investigators - not examined 
during the initial review - frequently begin to work under the grant 
after its initiation. Thus, monitoring these awards is an essential 
but increasingly difficult task, as in-house NIH employment ceilings are 
progressively reduced. 

The Question 

Would a proposal along the following lines preserve the best 

features of, and improve on the deficiencies in, program project/center 

i 

grants? 

1. Let the initiative for the creation of a program come 
from principal investigators with project support when 
they see merit in integrating their projects into a 
coherent unit. 

2. The signal of this consensus would be the submission of 

a request for core support which, by specified activities, 
facilitate the integration of the already funded projects. 
(This is not very different from Dr. Ames' general categorical 
support grant.) 



3 

3. The appropriate institute could negotiate the amount of 
core support and add to it, where appropriate, contract 
support for necessary activities more appropriately sup- 
ported by the latter mechanism. 

4. The core support could be expected to increase as the size 
and complexity of the effort expands, a process fundamentally 
achieved by an increase in the number of projects in the 
program. 

Putative Advantages 

The main advantage that would accrue to grantee institutions is 
that the bulk of major programs would be built upon existing research 
efforts; the distortion associated with major efforts, the bulk of 
which are new, is avoided. 

The major virtue as far as the NIH is concerned is that traditional 
study section review — in a style known to yield high quality evaluations — 
will operate. All major elements of a program will have passed muster 
and no significant new element will be addable without such review. 
Thus, both the NIH and the scientific community will gain a new respect 
for the research program blanketed in under the awards. At the same 
time, a high degree of ideological purity will have been maintained, with 
the proper instrument (grant or contract) being used in the most appropriate 
context. 

NIH staff may more effectively facilitate achievement of categorical 
missions through negotiations regarding such elements as: what projects 



A 
may properly be included; what activities are. to be supported at what 
level of intensity under a core grant; what contract support might be 
appropriate, etc. 

Possible Disadvantages 
The clear price for adopting this mechanism of support is an 
increase in the administrative and managerial load on the grantee 
institutions and especially on the staff of, and the advisors to, the 
NIH. Other probable losses: the program building potential of present 
program project and center grants. Likelihood of achieving "critical 
mass" on particular problem is substantially reduced because only those 
individuals who can meet national competition could be included. Also, 
where is the incentive for anyone to apply for one of these "core 1 " 
grants? (Many scientists would prefer to do their own thing rather than 
to cooperate unless there are big, clear benefits from their perspective) 

A Modest Proposal 
Set up a pilot study in one or two institutes involving: a 6.6 novo 
effort that would otherwise have been operated as a program project or 
center grant program; and the conversion of an existing program project 
or center grant program to the proposed modus operandi. Some criteria 
for aaccess should be established a priori and appropriate measurements 
taken throughout to attempt to demonstrate advantage in the changes. 
However, it should be recognized that the only palapable difference may 
be the degree of anxiety about quality felt by the government and 
academic participants. 



3=> 



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MEMO FOR THE RECORD: 



#11^ 



The attached material was used by Dr. Thomas J. Kennedy, Jr. at the Inter- 
council meeting on 1/29/74. (Material arranged in the order it was 
presented.) 



SEE ATTACHED 



A COUNT OF PUBLICATIONS BY 14 BIOMEDICAL NOBELISTS, 1972-73, 
-DERIVED FROM NLM'S MEDLINE, II 2k Ilk 



1972 1973 Total 



Anf ins en 


6 


6 


12 


Axelrod 


19 


11 


30 


Delbruck 





1 


1 


Edelman 


8 


6 


14 


Hershey 











Holley 


4 





4 


Khorana 


22 


2 


. 24 


Luria 


2 





2 


Moore 


6 


6 


12 


Nirenberg 


4 


3 


7 


Porter 


2 


1 


3 


Stein 





4 


4 


Sutherland 


2 


3 


5 


Von Euler 


3 





3 



Total 78 43 121 



© 



PUBLICATIONS OF C. B. ANFINSON, 1973 

Furie, B., Eastlake, A., Schechter, A. N. and Anfinsen, C. B. : The 
interaction of the lanthanide ions with staphylococcal nuclease. 
J. Biol. Chem. , 248: 2821-5, Aug. 25, 1973. 

Anfinsen, C. B. : Principles that govern the folding of protein chains. 
Science , 181: 223-30, July 20, 1973. 

Dunn, B. M. , Dibello,- C. and Anfinsen, C. B. : The pH dependence of the 
steady state kinetic parameters for staphylococcal nuclease-catalyzed 
hydrolysis of deoxythymidine-3'-phosphate-5 '-p-nitrophenylphosphate in 
H 2 and D 2 0. J. Biol. Chem. , 248: 4769-74, July 10, 1973. 

Sanchez, G. R. , Chaiken, I. M. and Anfinsen, C. B. : Structure-function 
relationships at the active site of nuclease-t'. J. Biol. Chem. , 248: 
3653-9, May 25, 1973. 

Fisher, W. R. , Taniuchi, H. and Anfinsen, C. B.: On the role of heme in 
the formation of the structure of cytochrome C. J. Biol. Chem. , 248: 
3188-95, Hay 10, 1973. 

Fuchs, S., Sela, M. and Anfinsen, C. B. : Nuclease-coated bacteriophage: 
a sensitive tool for studying antigenic reactivity of synthetic sequence 
fragments. ' Arch. Biochem. Biophys. , 154: 6C1-5, Feb. 1973. 



PUBLICATIONS OF J. AXELROD, 1973 

Saavedra, J. M. , Brownstein, M. and Axelrod, J. : A specific and 
sensitive enzymatic-isotcpic microassay for serotonin in tissues. 
J. Pharmacol. Exp. Ther . , 186: 508-15, Sept. 1973. 

Ciaranello, R. D. and Axelrod, J.: Genetically controlled alterations 
in the rate of degradation of phenylethanolamine N-methyltransferase. 
J. Biol. Chem ., 248: .5616-23, Aug. 25, 1973. 

Brownstein, M. , Eolz, R. and Axelrod, J.: The regulation of pineal 
serotonin by a beta adrenergic receptor. J. Pharmacol. Exp. Tner. , 186: 
109-13, July 19 73. 

Saavedra, J. M. and Axelrod, J. : Demonstration and distribution of 
phenylethanolamine in brain and other tissues. Proc. Natl. Acad. Sci . , 
70: 769-72, March 19 73. 

Wyatt, R. J., Saavedra, J. M. and Axelrod, J.: A dimethyltryptamine- 
forming enzyme in human blood. Am. J. Psychiatry- , 130: 754-60, July 1973. 

Saavedra, J. M. and Axelrod, J.: Effect of drugs on the tryptamine 
content of rat tissues. J. Pharmacol. Exp. Ther. , 185: 523-9, June 1973. 

Wooten, G. F. , Thoa, N. B. , Kopin, I. J. and Axelrod, J.: Enhanced 
release of dopamine-hydroxylase and norepinephrine from sympathetic 
nerves by dibutyryl cyclic adenosine 3', 5' -monophosphate and theophylline. 
Mol. Pharmacol .", 9: 178-83, March 1973. 

Ciaranello, R. D. , Jacobowitz, D. and Axelrod, J.: Effect of dexamethasone 
on phenylethanolamine N-=ethyltransferrase in chromaffin tissue of the 
neonatal rat. J. Neurochem. , 20: 799-805, March 1973. 

Saavedra, J. M. , Coyle, J. T. and Axelrod, J.: The distribution and 
properties of the nonspecific N-methyltransferase in brain. J. Neurochem. , 
20: 743-52, March 19 73. 

Axelrod, J.: Nobel prize winner talks about noradrenaline, nerves and 
aging. Geriatrics , 28: 42 passim, March 1973. 

Kreuz, D. S. and Axelrod, J.: Delta-9-tetrahydrocannabinol: localization 
in body fat. Science , 179: 391-3, Jan. 26, 1973. 



PUBLICATIONS OF M. DELBRUCK, 1973 

Ootaki, T. , Lighty, A. C. , Delbruck, M. and Hsu, W. J.: Complementation 
between mutants of phycomyces deficient with respect to carotenogenesis. 
Mol. Gen. Genet. , 121: 57-70, 1973. 



PUBLICATIONS OF G.M. EDELMAN, 1973 



Spear, P.G., Wang, A.L., Rutishauser, U. and Edelman, G.M. : Characteri- 
zation of splenic lymphoid cells in fetal and newborn mice. J. Exp. Med . , 
138: 557, Sept. 1, 1973. 

Gunther, G.R. , Wang, J.L. , Yahara, I., Cunningham, B.A. and Edelman, G.M. : 
Concanavalin A derivatives with altered biological activities. Proc. Natl . 
Acad. Sci. , 70: 1012-1015, April 1973. 

Edelman, G.M. : Receptor biophysics and biochemistry. The immune system. 
Neurosci. Res. Program Bull ., 11: 176-183, June 1973. 

\ Edelman, G.M. , Yahara, I. and Wang, J.L. : R.eceptor mobility and receptor- 
cytoplasmic interactions in lymphocytes. Proc. Natl. Acad. Sci. , 70: 
1442-1446, May 1973. 

Edelman, G.M. : Antibody structure and molecular immunology. Science , 180: 
830-840, May 25, 1973. 

Edelman, G.M. and Moller, G. : The immune system as a model for cellular 
maturation and differentiation. Neurosci. Res. Program Bull. , 11: 1-154, 
March 1973. 



PUBLICATIONS OF H.G. KHORANA, 1973 



Cashion, P.J., Fridkin, M. , Agarwal, K.L., Jay, E. and Khorana, H.G. : Use 
of trityl- and -naphthylcarbamoylcellulose derivatives in oligonucleotide 
synthesis. Biochemistry , 12: 1985-1990, May 8, 1973. 

Loewen, P.C. and Khorana, H.G.: Studies on polynucleotides. CXXII. The 
dodecanucleotide sequence adjoining the C-C-A end of the tyrosine transfer 
ribonucleic acid gene. J. Biol. Chem. , 248: 3489-3499, May 25, 1973. 



PUBLICATIONS OF S. MOORE, 1973 



Hugli, T.E., Bustin, M. , Moore, S. : Spectrophotometric assay of 
2',3'-cyclic nucleotide 3 '-phosphohydrolase : Application of the 
enzyme in bovine brain. Brain Res. , 58: 191-203, Aug. 17, 1973. 

Hayashi, R. , Moore, S. , Merrifield, R.B.: Preparation of pancreatic 
ribonucleases 1-114 and 1-115 and their reactivation by mixture 
and synthetic COOH-terminal peptides,.* J. Biol. Chem. , 248: 3889-92, 
June 10, 1973. 

Moore, S. , Stein, W.H. : Chemical structures of pancreatic ribo- 
nuclease and deoxyribonuclease. Science , 180: 458-64, May 4, 1973. 

Hayashi, R. , Moore, S., Stein, W.H. : Carboxypeptidase from yeast. 

Large scale preparation and the application to COCH-terminal analysis 

of peptides and proteins. J. Biol. Chem. , 248: 2296-302, Apr. 10, 1973, 

Liao, T.H. , Salnikow, J., Moore, S. , Stein, W.H. : Bovine pancreatic 
deoxyribonuclease A. isolation of cyanogen bromide peptides; complete 
covalent structure of the polypeptide chain. J. Biol. Chem., 248: 
1489-95, Feb. 25, 1973. 

Salnikow, J., Liao, T.H., Moore, S. , Stein, W.H. : Bovine pancreatic 
deoxyribonuclease A. isolation, composition, and amino acid sequences 
of the tryptic and chymctryptic peptides. J. Biol. Chem., 248: 
1480-8, Feb. 25, 1973. 



PUBLICATIONS OF M.W. NIRENBERG, 1973 



Thompson, E. J. , Wilson, S.H. , Schuette, W.H., Whitehouse, W.C., 
Nirenberg, M.W. : Measurement of the rate and velocity of movement 
by single heart cells in culture. Am. J. Cardiol. , 32: 162-6, 
Aug. 1973. 

Greene, L.A. , Sytkowski, A.J. , Vogel,-Z., Nirenberg, M.W. : 
Bungarotoxin used as a probe for acetylcholine receptors of 
cultured neurones. Nature, 243: 163-6, May 18, 1973. 

Sytkowski, A.J. , Vogel , Z., Nirenberg, M.W. : Development of 
acetylcholine receptor clusters on cultured muscle cells. Proc. 
Natl. Acad. Sci., 70: 270-4, Jan. 1973. 



PUBLICATIONS OF R.R. PORTER, 1973 

Porter, R.R. : Structural studies of immunoglobulins. Science, 180: 
713-6, May 1973. 



r% 



PUBLICATIONS OF W.H. STEIN, 1973 



Moore, S. and Stein, W.H. : Chemical structures of pancreatic ribonuclease 
and deoxyribonuclease. Science , 180: 458-464, May 4, 1973. 

Hayashi, R. , Moore, S. and Stein, W.H.: Carboxypeptidase from yeast. Large 
scale preparation and the application to COOH-terminal analysis of peptides 
and proteins. J. Biol. Chem. , 248: 2296-2302, April 10, 1973. 

Liao, T.H., Salnikow, J., Moore, S. and Stein, W.H. : Bovine pancreatic 
deoxyribonuclease A. isolation of cyanogen bromide peptides; complete 
covalent structure of the polypeptide chain. J. Biol. Chem. , 248: 1489- 
1495, February 25, 1973. 

Salnikow, J., Liao, T.H. , Moore, S. and Stein, W.H. : Bovine pancreatic 
deoxyribonuclease A. isolation, composition, and amino acid sequences of 
the tryptic and chymotryptic peptides. J. Bicl. Chem. , 248: 1480-1488, 
February 25, 1973. 



PUBLICATIONS OF E.W. SUTHERLAND, 1973 



Schultz, G. , Hardman, J.G. , Schultz, K. , Davis, J.W. and Sutherland, E.W. : 
A new enzymatic assay for guanosine 3':5'-cyclic monophosphate and its 
application to the ductus deferens of the rat. Froc. Natl. Acad. Sci. , 
70: 1721-1725, June 1973. 

Johnson, R.A. and Sutherland, E.W. : Detergent-dispersed adenylate cyclase 
from rat brain. Effects of fluoride, cations, and chelators. J. Biol. Chem, 
248: 5114-5121, July 25, 1973. 

Peytremann, A., Nicholson, W.E., Liddle, G.W. , Hardman, J.G. and Sutherland, 
E.W. : Effects of methylxanthines on adenosine 3 ' ,5 '-monophosphate and 
corticosterone in the rat adrenal. Endocrinology , 92: 525-530, February 
1973. 




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Status of Funding of NIH/NIMH Sponsored Research* 

When Drs. Sherman and Morgan asked me earlier this month to address 
today's meeting, I agreed with what now appears to have been unseemly 
haste. Liberated from Federal employment, I was chomping at the bit to 
exercise my new freedom and to speak my mind. Alas and alack, I had for- 
gotten one important concomitant of retirement: I no longer had at my disposal 
that splendid well oiled machine of professionals in the front office at the NIH 
that has been so effective in the selection, collection, analysis and interpretation 
of data. I thus appear before you this afternoon as one in a superb position 
to say a great deal about very little. Under these circumstances, preparing 
this talk has been most instructive for me, specifically in respect to three 
considerations: perspective, data and analyses. I should like to amplify on 
these aspects later if time permits. And fortunately, I was able to persuade 
my former colleagues at the NIH to give me a hand, despite their preoccupation 
■with pulling together data for their own presentation today to the Presidents Panel. 

The first slide depicts NIH research expenditures since FY I960. The 
total height of each bar is in current dollars; the solid component is in constant 
dollars while the clear part reflects the loss to inflation. For the budget 
watchers in the crowd, the biomedical research deflator used was recently 
developed under the auspices of the NIH; it is slightly different from, and 
more realistic than, the overall GNS implicit price deflator. 



^Presented before the Spring Meeting, Council of Academic Societies, 
Association of American Medical Colleges (AAMC), March 31, 1975. 



It can be seen that the total research budget grew apace until FY 1968, 
then experienced a couple of bad years, and later resumed its upward trend. 
In point of fact, the total obligations projected for FY 1975 are just short of 
double the prior peak level of FY 1968. 

However, if one asks the question: "how much more research has the 
NIH been able to buy?", the answer is considerably less than twice as much. 
By comparing the heights of the solid bars in FYs 1968 and 1975, it may be 
seen that the increase in real dollars over that period is only about 35%. In 
terms of resources available at the bench and at the bedside, it should be 
recalled that indirect costs rates on research project, program project and 
center grants have been rising, so that a shrinking fraction of the total award 
is available for the actual research. The second slide depicts the rising 
indirect cost rates since 1967, slightly higher for regular research project 
than for program projects and center grants, but on the average increasing 
from 18. 6% to 31. 7% of direct costs. Restated somewhat differently: while 
direct research costs have increased about 65%, indirect costs have risen 
by about 180%. Thus, the funds actually available to the scientist for research 
were overstated by the heights of the solid bars in the first slide. The indirect 
cost increases either have purchased new support services for research -- 
better accounting records, better management, better central services --, or 
have reflected an entirely appropriate transfer to the Federal sponsor of costs 
previously borne by the institution. But in either case the funds available 
for direct research have been reduced. 

When the effect of inflation and indirect costs are taken into consideration, 
the growth in resources for research itself are indeed small. 

Aggregated data is of limited usefulness. Let me disaggregate in several 
different ways. The third slide is a summary derived by selecting every fifth 



-3- 

year, and about a third of the budget category items from a larger table 
of NIH expenditures that I hope will be available to you after this talk or in 
its published version. In this slide, some of the components of the bar 
graph shown a moment ago are looked at separately. "When intramural and 
administrative costs are subtracted from the total budget, the remainder 
defines the total extramural program. Most of this is research, whether 
grant or contract. However, from 15-30% -- or in FY 1975, a little more 
than $200 million -- will be allocated to support training and (cancer) construc- 
tion. Budget watchers have traditionally liked to track the flow of these funds 
into academic institutions in general and into medical schools in particular; 
accordingly, cognate data have been included in the table. It is quite haz- 
ardous, at least in principle, to estimate distributions by class of institutions 
before study section and council decisions have been made, and so data for the 
lower cells on the right are not available for FY 1975; the FY 1974 value 
for total academic science was $1, 214 million and for medical school academic 
science $913 million. 

Comparisions are facilitated by normalizing each item for some standard 
year, and in the table shown in the fourth slide, all figures have been compared 
to their value in I960, arbitrarily set at 100. In parentheses is the value ob- 
tained when constant , rather than current , dollars are used as a basis for 
comparison. Again two cells are vacant. The FY 1974 values are 333 and 
365 respectively for the constant dollar index for academic and medical 
academic science. A couple of observations are warranted. 

• The total budget growth has been paralleled throughout by extramural 
program growth, and a more or less constant fraction has gone into 
academic science, at least until about 1972. Since then, the academic 
sector has borne the brunt of oscillations produced by vagaries in 



in research, training and general research support, occasioned 
by administration proposals and court disposals. 

• Over the years, there has been a slight tendency for funds to medical 
schools to grow more rapidly than the total extramural program or 
than academic science. Again, the data for the last couple of years 
reflect a complex and turbulent situation. . 

• Until recent parlous times, obligations for training grew, but more 
slowly than extramural program. Clearly, compared to fellow- 
ship support, training grants were the more favored instrument for 
the support of training until the recently enacted legislation governing 
this activity. 

• Extramural research in the form of grants and contracts was the most 
rapidly growing component of the extramural program throughout the 
15 year period under discussion. 

Before leaving this slide, I direct your attention once more to the enormous 
difference, seen in each cell, between the apparent growth, in the upper index 
value, and the real growth, in parentheses. 

You will recall from the first slide that the current dollar expenditures 
in FY 1975 were estimated to be about double those in FY 1968. The fifth 
slide, disaggregating in another way and focusing on extramural awards of 
four different types, reflects this same set of facts. In toto, an increment of 
between $750-800 million has been added to the obligations of the NIH in- 
stitutes between FYs 1967 and 1974. Visible in absolute terms on your left 
but more strikingly so in relative terms on your right, are the facts that: 

• Awards for contracts have expanded sharply. 

• Awards for program project and center grants have expanded 
moderately. 



-5- 

e Expansions in activities which connote a high degree of centralized and 
governmental programming were at the expense of research project 
grants which connote a high degree of individual investigator initiative. 

If disaggregation is carried a step further, additional insight is provided. 
The sixth slide shows that the bulk of the growth since FY 1968 or more pre- 
cisely since FY 1971, has been in three of the institutes: NCI, NHLI and 
NICHD, while the others have expanded only modestly. Indeed, if corrections 
■were made for inflation and for indirect cost increases, the group of institutes 
on the right hand side would demonstrably have contracted. 

The seventh slide indicates that the shift away from regular grants is almost 
entirely attributable to the actions of the three rapidly growing organizations. Note 
that the fractional distribution of awards is almost invariate for the more slowly 
growing institutes on your right, while on the left, the fraction allocated to 
regular project grants shrank strikingly from FY 1968 to FY 1972. 

The eighth slide in this series examines the behavior patterns of each of 
the three growing institutes over the epoch FY 1967 to FY 1974. In the cate- 
gories under examination, NCI has grown most rapidly. It has approximately 
doubled its investments in research project grants and quintupled that in 
contracts. NHLI has expanded grants by about 30% and like cancer quintupled 
its investments in contracts. 



-6- 

! 

Against the background data let me return to the matters I mentioned 
in opening - perspective, data and analysis. 

Trends can be identified with certainty only if one examines an extended 
time series. Major and minor turbulences may characterize a short epoch 
but only from the long view can one be sure whether a trend had begun or a 
transient experienced. We are too close to FYS 1972-1975 to distinguish 
these, and 'when one is wearing the historian's hat, decision must be deferred. 

In contrast to the historian, the activist wants to influence the course of 
history and is motivated by prior convictions about the direction in -which 
events should be moving. For such individuals, short-term objectives and 
current data are of overwhelming importance. Budget watching for the 
activist requires a much more continuing and intense effort. The budgeting 
process is a long one, confidential within the Federal agencies for about a 
year until the formal presentation of the Presidents budget each January, and 
then public until the appropriation act is signed. The process is characterized 
by the emergence of a number of discrete budgets, including those of the 
President, the House Appropriations Subcommittee and Committee, the House 
itself, the Senate Appropriations Subcommittee and Committee, the Senate 
itself, and the House-Senate Conference Committee. If either body fails to 
approve the recommendations of Conferrees, recycling in order; if the 
President fails to sign or vetoes the appropriation bill, recycling again will 
occur. Thus there are a minimum of four budgets that must be kept in mind 
each year for those following short term changes. 

Those facts bring me to a couple of conclusions, which I offer for your 
considerations. 

e Most of us overreact to one event in a very large trackmeet -- the 

publication of the President's Budget. This action stimulates knee-jerk 



-7- 



responses all over Washington, with a spate of analyses pouring forth 
from every quarter. In my view this unduly emphasizes one event and 
obscures others of at least equivalent import. The President's budget 
has increasingly become less a rational fiscal plan for Federal expen- 
ditures than a strategic and tactical weapon in the President's continuous 
struggle to impose his will on overall Federal financing. Let me 
illustrate the transient character, as well as some other properties 
of the President's budget with the ninth slide. President Ford's 
recently submitted budget listed the actual FY 1974, the estimated FY 
1975 and the proposed FY 1976 obligations for each activity. 
The so-called "FY 1974 actual" showed a total of $1, 737 million, the 
estimate for FY 1975 -the current year- was $1, 691 and the FY 1976 
proposal was for $1, 753. The amounts in the document are tabulated 
in the 1st, 4th and 5th budget entries. What do they say? 
• Compared to the FY 1974, - the one rock solid figure now available - 

the President was estimating that there would be an overall 2. 7% decrease 
this year, followed by a 3. 7% increase in the next year. The aggregate 
small FY 1975 decrease was the resultant of a substantial increase in 
NCI, stability in NHLI and a substantial decrease in all other in- 
stitutes. For the following year, the aggregate 3. 7% increase was made 
up of a significant rise in cancer expenditures with modest growth in all 
other institutes. Thus the formal document submitted to Congress 
suggested a small reduction in the current year but a modest rise 
in the upcoming year, 
a But where did the President get those figures shown in the 4th budget 
entry line. In his, or more correctly, Mr. Nixon's, submission a year 
before a modest aggregate increase had been proposed, as shown by 



-8- 

the second budget entry item, with NCI and NHLI profiting at 
the expense of the other Institutes. The Congress did not accept 
the President's recommendation last year, and added large sums 
to those he proposed, while maintaining the same relative categorical 
emphasis. Since the recent resolution of a number of issues -such as 
the AAMC suit on impoundment- -there would normally be every ex- 
pectation that the amounts appropriated would be available for ex- 
penditure, and that this appropriation figure, duly signed into law, 
would become the FY 1975 column of the FY 1976 budget. But Public 
Law 93-344, recently enacted, and entitled the Congressional Budget 
and Impoundment Control Act, now permits the President to request 
Congressional approval to rescind or reserve appropriated funds. 
Just before the budget was submitted, the President sent a special 
message to Congress proposing rescissions and, on the assumption 
that the Congress would approve, used the appropriation revised by 
rescissions as the basis for the estimate of FY 1975 expenditures in the 
formal budget message. 

Had the President not taken this course, he would have had to present as 
the estimate of 1975 expenditures the third entry, the actual appropriation. 
The impact of that alternative is evident in the last two lines of the - 
table. Instead of being able to claim a modest across-the-board increase, 
he would have had to admit that his budget proposal was to decrease 
obligations by 14% in the aggregate and by almost 17% in the less 
favored Institutes. 

Without making any value judgments, this recital should make clear 
that the President's Budget is calculated with skill, finesse and 
artifulness to place in the best of all possible lights the actions 



of a President determined to hold down one class of public expenditures. 
The best possible face has been placed on what might clearly be an 
unpopular action. A few people may be misled; many will be confused. 
• This table also says something about the pace at which data becomes 
obsolete. The President's Budget message became available about 
the 1st of February. His rescission message was disapproved by the 
House on March 8, 1975. By that action, the estimate of FY 1975 
expenditures became the congressional appropriation, not the rescission 
proposal. Thus, within less than six weeks of publication, that part of 
the President's budget dealing with the increases and decreases in FY 
1976 compared to the present year, became obsolete. The parlimentary 
situation now is that the FY 1976 budget proposes a sharp reduction - about 
15% - over a now quite hard estimate of current year expenditures. 
Perhaps I have devoted too much attention to this slide, but I wanted to 
emphasize the difficulties of budget watching for the activists who, not content 
with observing long-term trends, are concerned with influencing the course of 

history. 

Which brings me to another aspect of budget watching - data acquisition. 
This is no easy task in the rapidly moving events of any single budget cycle. 
The data on congressional action is public, if one knows where and when to 
look for it. Each Federal agency of course tracks the process closely and top 
level managers are fully aware of the generalities at each step. But even a 
key Federal official in such an Agency must rely on one or two individuals 
for absolutely up to date and detailed information about his own Agency, and 
will often have trouble acquiring data on budgets of other agencies. The 
NSF budget for instance progresses through a different Congressional 



-10- 

committees than that of the NIH, with hearings, mark-ups, committee reports, 
floor debates, etc. , occurring at variable times. It seems to me that there 
is a pressing need for a private -sector non-governmental office to collect and 
maintain data on Federal funding of biomedical research, providing reliable 
and timely short term as well as historical data in the form of approrpiate 
publications. The problems of data collection involve more than good leg 
work. Sophisticated understanding of the organization and programs of the 
Federal agencies are required to maintain comparability of data over the years 
when programs are born or die, move to newly created agencies, return to 
old homes, settle down with the parent organizations in new bureaucratic niches, 
etc. In addition there are many classification problems -should career awards 
be assigned to the category "training" or "research"? which must also be 
resolved. Thus the proposed office would have more than a routine task 
to carry out. 

Why an office outside government? For one reason, no single government 
agency has all the data readily available. On short notice, I was unable to 
cover for you today both NIH and NIMH because my contacts at the NIH didn't 
have reliable NIMH data at their fingertips. For another, Federal agencies 
are not always either eager or permitted to supply data, especially when there 
is a reasonable basis to suspect that the information could be used to argue 
against an administration position. 

The final lessons I learned in preparing this talk related to data analysis. 
Analytical insights come from working over data, and usually require interative 
processes with new data requirements emerging as new hypotheses are formulated. 
I had never noticed until looking over data this weekend that the three growing 
institutes, within an essentially constant total budget, expended less on research 
project grants and more on research contracts during the period from FY 1967 
thru FY 1970. Did their differential behavior during this period provide the 



-11- ; 

impetus for their subsequent rapid growth? New ideas, - some good some bad - 
will be the inevitable consequence of collecting and organizing data. 

Another facet of the relationship between acquisition and analysis relates 
to the level of aggregation with which one ought to be content. Even today's once- 
over-lightly makes clear that important realities are obscured by aggregation 
and that without detailed data, significant trends can be obscured. NIH, for 
example, is not a monolith. Clearly, some of its constitutent institutes have 
experienced quite different histories over the last decade. I suspect that with 
deeper analysis, each could be shown to be unique in reference to some specific 
property. 

These are subtle problems of analysis which should be mentioned, but for 
which easy solutions are not available. 

• Identical words often are used to describe different concepts. Starting with 
James A. Shannon, a succession of NIH directors insisted that funds for 
training be used to develop investigators; if an individual should in- 
cidentally receive advanced clinical training for practice, such was 
regarded as an unwanted but unavoidable secondary effect. In recent 
years, as training programs came under fire, evidence began to 

emerge that, to at least some degree, NIH training funds were used 
for routine residency training. Both NIH staff and university program 
directors spoke of "training;" each, at least in some instances, 
attached differing meanings to the word. 

• Boundaries of concepts are not clear. What is research? Where does 
it stop and where does development or patient care begin? To what 
extent have the very large marginal increases in the expenditures of 
of the NCI been devoted to research, as that activity is traditionally 
defined. 



-12- 

e Instruments of support may have assumed unreal properties. 
How really different is a grant from a contract? When the NCI 
announces a new instrument of support called a grant, has the leopard 
changed its spots? Or does a rose under any other name, smell the 
same? Is creative work possible only under grants? Must contracts 
be all routine "scut" work. 

9 Basic perceptions and frameworks for interpretation bias conclusions. 
Perhaps one of the most interesting sources of noise in the system and 
divergence among analysts stem from radical differences in the per- 
ceptions of individuals of what sort of a system the data describe. The 
most dramatic example of this in my opinion appeared in Dean 
Robert Ebert's Presidential address to the Association of American 
Physicians. Ebert's basic concept of the rational for Federal 
investments appears, at least to me, to be sharply at variance with the 
historic positions of the NIH bureaucracy. Nor should there be any 
mistaking the fact that the long-range future of research may depend 
heavily on which of these views prevail. The NIH position has long 
been that there are a host of unsolved problems in the understanding 
of disease, and that better health for the American people is abso- 
lutely contingent upon finding solutions thru research. The NIH budget 
is designed as a national agenda for research, offered to the President 
and the Congress as such, and, in the view of the NIH, bought as such 
by these institutions of government. That the major performers turn 
out to be medical schools is not the result of deliberate choice, simply 
the lack of competent competitors. Over time, the fact that so much 
of the national agenda was executed in academic institutions led to concern 
for those organizations, not per se but as instruments for both carrying 



-13- 

out the research and for training the manpower to do so in the future. 
The concern was for universities as means , not ends. 
The nation has, it seems to me, given generously to research over 
the years, recognizing - however dimly - that new knowledge held out 
the only hope for enhancing the quality and extending the duration of 
life, and that this new knowledge could be acquired only thru research. 
Ebert takes a profoundly different view of the basis for Federal research 
investments in schools of medicine. Implicit in his address is the prem- 
ise that these funds should support universities as an end not a means . 
Under such a scheme, the disposition of research funds should be heavily 
influenced by the faculty of the institution and tailored to fit its educa- 
tional objectives. The prevailing Federal view and Dean Ebert' s could 
not be more divergent. 

There does not seem now to be a clear national consensus on the propri- 
ety of Federal aid to medical education. Historically, such assistance 
has been hard to negotiate, has come into being long after research 
investments were flourishing and has a fairly uncertain future. Invest- 
ments in medical schools to carry out a national agenda for research 
look promising. Investment prospects for other purposes look bleak 
until the public's quid for its investment quo is more demonstrable 
qualitatively and quantitatively. 
Fundamentally the objective of analysis is to reach a judgment on the value 
of the several dimensions of the enterprise. And here, we move into an even 
more complex, controversial and significant era. What do these trends mean? 
Are they good or bad? For example, 

e How much should the nation be spending on biomedical research? Is 
the present level enough? Is the present growth rate adequate? By 
what norms and criteria? 



-14- i 

• Is the distribution by category squewed, with too much in pockets 
such as cancer, heart/lung, population and too little in allergy, 
arthritis, preclinical sciences? By what criteria should distribution 
by these categories be determined? Have the categories themselves 
become outmoded? With what should they be replaced? 

• Is applied research and development oversupported? Is the direction 
in which the NCI, NHLI and NICHD seem to have moved good or bad? 
Is the national research program relevant to the pressing problems 
of disease, or not? Can -we measure relevance? 

It is this set of questions that is at the heart of any exercise to examine 
trends in the support of biomedical research. We all subscribe to the central 
dogma that research is an endless frontier. The key question is how can the 
frontier be advanced most purposefully, broadly and deeply, thru the skillful 
and intelligent deployment of resources. I could agrue that there are no final 
answers to most of the most significant questions. The best that can be 
hoped for is that intelligent and influential people •will be able, given suitable 
data on a timely schedule, to converge on congruent decisions for action. I 
hope this presentation will have facilitated such a convergence. 



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